Pharmacy / Compounding

Fagron BV

FDA issued a warning letter to Fagron BV (operating as Fresenius Kabi Compounding, LLC / Fagron Sterile Services in Canton, MA), a registered 503B outsourcing facility, following an October–November 2025 inspection that revealed serious sterility assurance deficiencies in the production of sterile drug products. Investigators found that operators blocked first-air to sterile vials, smoke studies were inadequate, environmental monitoring was insufficient, and the quality unit failed to act on known adverse trends involving defective IV bags — all causing drug products to be adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B). The facility had already initiated a voluntary recall in February 2026 of affected lots, but FDA found multiple corrective action responses inadequate or unsupported by documentation. FDA warned that failure to adequately address violations may result in seizure or injunction.

Purolea Cosmetics Lab

FDA issued a warning letter to Purolea Cosmetics Lab (Livonia, MI) after a October 2025 inspection found the facility manufacturing adulterated homeopathic drug products under insanitary conditions, with multiple CGMP violations including failure to conduct microbiological testing, component identity testing, and adequate quality unit oversight. Two products — 'Dermveda Extra Strength Shingles Relief' and 'Dermveda Extra Strength Ultra Genital Herpes Relief' — were identified as unapproved new drugs marketed for serious conditions (shingles and genital herpes) without FDA approval. The firm also improperly relied on AI-generated compliance documents without human QU review. FDA warned that failure to address violations may result in seizure, injunction, and withholding of approvals, and required a written response within 15 working days.

Alan Health Technologies Inc. dba Alan

FDA issued a warning letter to Alan Health Technologies Inc. dba Alan (Brooklyn, NY) on February 20, 2026, after reviewing the company's website alanmeds.com in December 2025. The agency found that Alan's website displayed compounded semaglutide and tirzepatide products with the 'Alan' brand name on the pictured labels, falsely implying Alan was the compounder of those drugs when it was not. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the introduction of these products into interstate commerce violates section 301(a). Alan was given 15 working days to respond with corrective steps, and failure to comply could result in seizure or injunction.

NewSelf Limited dba NewSelf

FDA issued a warning letter to NewSelf Limited dba NewSelf on February 20, 2026, concerning its website marketing of compounded semaglutide and tirzepatide products. The agency found the website made false or misleading claims by displaying the 'NewSelf' label on drug products it does not compound, and by using language implying FDA approval for compounded drugs that have not been approved. These representations render the products misbranded under FDCA sections 502(a) and 502(bb), and their interstate commerce introduction violates section 301(a). NewSelf was given 15 working days to respond with corrective steps, and was warned that failure to act may result in seizure or injunction.

Ivim Services LLC dba Ivim

FDA issued a warning letter to Ivim Services LLC dba Ivim, a telehealth company based in Columbus, OH, after reviewing its website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with labeling that falsely identified 'Ivim' as the compounder when it is not. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA required a written response within 15 working days describing corrective steps, and warned that failure to adequately address violations may result in seizure or injunction.

Viv Health, Inc. dba VIV RX

FDA issued a warning letter to Viv Health, Inc. dba VIV RX, a telehealth company based in Austin, TX, for misbranding compounded semaglutide and tirzepatide products on its website. The core violation is that the product labels depicted on the website identify 'VIV RX' as the compounder when VIV RX is not actually the compounder, constituting false or misleading labeling under FDCA sections 502(a) and 502(bb). FDA found these products to be misbranded drugs introduced into interstate commerce in violation of section 301(a) of the FDCA. The company was given 15 working days to respond with corrective steps, and FDA warned that failure to comply may result in seizure or injunction.

Refills Health, LLC dba Refills Health

FDA issued a warning letter to Refills Health, LLC (dba Refills Health) on February 20, 2026, after reviewing the company's website in December 2025 and finding false or misleading claims related to compounded semaglutide products. The website falsely identified Refills Health as the compounder of the drugs on product labels, and made claims implying FDA approval or clinical validation for products that have not been FDA-approved. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

A. Nelson & Co. Ltd.

FDA issued a warning letter to A. Nelson & Co. Ltd., a London-based homeopathic drug manufacturer, following an unannounced inspection in September 2025. The agency found significant CGMP violations including failure to conduct adequate microbial testing on each batch before release (including products for children as young as two), extending expiration dates without adequate stability data, and serious data integrity failures involving improper disposal of quality records and uninvestigated out-of-trend results. FDA warned that continued non-compliance could result in refusal of admission of the firm's products into the United States and withholding of approval for new applications.

Bio-Medical Pharmaceutical Manufacturing Corporation

FDA issued a warning letter to Bio-Medical Pharmaceutical Manufacturing Corporation (Houston, TX) following a August 2025 inspection that found significant CGMP violations in the manufacture of OTC sterile drug products. The facility lacked classified cleanrooms, ISO 5 aseptic filling conditions, validated sterilization and cleaning processes, and adequate release testing including sterility testing, rendering its drug products adulterated under section 501(a)(2)(B) of the FD&C Act. FDA also cited failure to list the drug product '(b)(4) Solution' in eDRLS and recommended removal of distributed batches from the U.S. market, which led to a voluntary recall by the distributor. The letter warns that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.

Apollo Care, LLC

FDA issued a warning letter to Apollo Care, LLC, a 503B outsourcing facility in Columbia, MO, following a March 2025 inspection that revealed serious sterility assurance deficiencies in the production of sterile compounded drug products. The facility was found to have produced adulterated drugs under FDCA sections 501(a)(2)(A) and 501(a)(2)(B), including insanitary conditions, inadequate microbial contamination controls, and multiple CGMP violations. Apollo Care had already initiated a voluntary recall of a fentanyl/ropivacaine lot due to lack of sterility assurance, but FDA found several corrective action responses inadequate or insufficiently documented. FDA demands a written response within 15 working days and warns that failure to adequately address violations may result in seizure or injunction.

Boothwyn Pharmacy, LLC

FDA issued a warning letter to Boothwyn Pharmacy, LLC (Kennett Square, PA) following a May–June 2025 inspection that revealed serious deficiencies in sterile compounding practices. The pharmacy distributed GLP-1 injectable products (Semaglutide, Tirzepatide) and other sterile preparations that failed sterility testing and were subpotent relative to their labeled strengths, rendering them adulterated and misbranded under the FDCA. The firm had already initiated a voluntary recall and ceased GLP-1 sterile production, but FDA found corrective action responses inadequate due to missing documentation and contradictory SOPs for at-risk product release. FDA demands a written response within 15 working days and warns that failure to correct violations may result in seizure or injunction.

MedisourceRx

FDA issued a warning letter to MedisourceRx, a 503B outsourcing facility in Los Alamitos, CA, following a May–June 2025 inspection that found the facility failed to meet section 503B conditions, primarily by not submitting required adverse event reports and maintaining inadequate adverse event reporting procedures. Because these conditions were not met, MedisourceRx's compounded drug products lost eligibility for exemptions from FDA approval requirements, rendering them unapproved new drugs and misbranded products under the FDCA. FDA found the facility's corrective responses partially deficient, noting that submitted procedures still did not adequately define 'serious' adverse events consistent with 21 CFR 310.305(b). The letter warns that continued non-compliance may result in seizure or injunction, and requires a written response within 15 working days.

Medinatura New Mexico, Inc.

FDA issued a warning letter to Medinatura New Mexico, Inc. (Albuquerque, NM) following a May 2025 inspection of their homeopathic drug manufacturing facility. The agency found significant CGMP violations including failure to adequately test incoming components for identity and purity (including hazardous ingredients linked to lethal poisoning incidents), an inadequate cleaning validation program that risked cross-contamination across multiple drug products, and a process validation program that had not been updated since 2007. FDA warned that failure to correct these violations could result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.

Wells Pharma of Houston, LLC

Wells Pharma of Houston, LLC, a 503B outsourcing facility in Houston, TX, received an FDA Warning Letter following a March 2025 inspection that identified serious CGMP deficiencies and failures to meet section 503B conditions. The facility produced sterile drug products (including Fentanyl and Phenylephrine formulations) under insanitary conditions—including cracked laminar airflow hood plexiglass, inadequate smoke studies, and deficient media fills—rendering them adulterated. Drug products also lacked required 'This is a compounded drug' labeling and the facility had inadequate adverse event reporting procedures, causing products to be ineligible for 503B exemptions and thus constitute unapproved new drugs and misbranded products. FDA demanded a written corrective action response within 15 working days and warned that failure to comply may result in seizure or injunction.

Miers Laboratories, Ltd

FDA issued a warning letter to Miers Laboratories, Ltd (New Zealand) following a May 2025 inspection that found significant CGMP violations in the manufacture of homeopathic drug products intended for the U.S. market. Key violations included failure to perform identity testing on incoming components — including a solvent with potentially lethal contamination — and use of an active pharmaceutical ingredient more than 14 years past expiration, as well as inadequate quality unit oversight. These are repeat violations from 2014 and 2019 inspections; FDA has placed all drugs from this firm on Import Alert 66-40, effectively blocking U.S. importation.

Uriel Pharmacy, Inc.

FDA issued a warning letter to Uriel Pharmacy, Inc. (East Troy, WI) following a February–March 2025 inspection that found significant CGMP violations including inadequate in-process testing, component identity testing failures, and deficient quality control unit oversight. In addition, FDA determined that seven homeopathic ampule drug products sold on shopuriel.com are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, with serious public health concerns because the glass ampule packaging mimics sterile injectable containers and the products have been documented being injected by clinicians despite oral-use labeling. FDA warned that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications, and required a written response within 15 working days.

PQ Pharmacy, LLC

FDA issued a warning letter to PQ Pharmacy, LLC (Brooksville, FL), a 503B outsourcing facility, following a March–April 2025 inspection that found serious sterile manufacturing deficiencies and failure to meet 503B conditions. The facility produced adulterated drug products due to insanitary conditions and CGMP violations, including poor aseptic practices, inadequate smoke studies, and failure to investigate batch discrepancies. Drug products — including semaglutide vials and ophthalmic solutions — were found to be unapproved new drugs and misbranded. FDA demanded a written corrective action response within 15 working days and warned that failure to comply may result in seizure or injunction.

Revive Rx LLC dba Revive Rx Pharmacy

FDA issued a warning letter to Revive Rx LLC dba Revive Rx Pharmacy (Houston, TX) following a January–February 2025 inspection that identified serious insanitary conditions in sterile drug compounding operations. The facility exposed sterile drug products to worse than ISO-classified air quality, failed to perform adequate media fills and smoke studies under dynamic conditions, and did not conduct sufficient environmental monitoring in aseptic processing areas. FDA found these practices caused drug products to be adulterated under section 501(a)(2)(A) of the FDCA, and the firm's corrective action responses were deemed deficient or insufficiently documented. The agency warned that failure to adequately address violations may result in seizure or injunction.

Turbare Manufacturing

FDA issued a warning letter to Turbare Manufacturing, a 503B outsourcing facility in Conway, Arkansas, following a January 2025 inspection that found serious sterile manufacturing deficiencies. The facility failed to conduct adequate process simulation (media fill) studies, investigate batch discrepancies, establish proper acceptance criteria for quality control, and maintain adequate environmental monitoring in aseptic processing areas. FDA found the drug products adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B), and the firm had already initiated a voluntary recall of Bevacizumab lots due to lack of sterility assurance; FDA warned that failure to adequately address violations may result in seizure and injunction.

EA WORKS Limited Liability Company dba Trust Labs

FDA issued a warning letter to EA WORKS LLC dba Trust Labs (operating as coretrustlabs.com) in September 2025 for unlawfully selling unapproved and misbranded compounded drug products — including retatrutide, semaglutide, and tirzepatide — to U.S. consumers via the internet. Compounded retatrutide products were cited as unapproved new drugs and misbranded because retatrutide does not appear on the 503A or 503B bulk drug substances lists and is not a component of any FDA-approved drug. Additionally, website claims implying that compounded semaglutide and tirzepatide are FDA-approved were found to be false or misleading. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Canada Med Stop

FDA issued a warning letter to Canada Med Stop, a Vancouver-based online pharmacy, after reviewing its website in August 2025 and finding false or misleading claims about compounded semaglutide products offered to U.S. consumers. The site claimed its products contained the 'same active ingredient in branded weight loss medications,' were 'FDA-Approved,' and were 'GENERIC' — all of which are false or misleading because compounded drugs are not FDA-approved. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), and warned that failure to correct violations may result in seizure or injunction.

ASN-LABS

FDA issued a warning letter to ASN-LABS (Honolulu, HI) in September 2025 after reviewing their website and finding they were selling compounded retatrutide and semaglutide products unlawfully. The compounded retatrutide products were cited as unapproved new drugs and misbranded drugs because retatrutide does not appear on the 503A or 503B bulks lists and is not an FDA-approved drug component. Additionally, ASN-LABS' website claims about compounded semaglutide were found to be false or misleading because they implied equivalence to FDA-approved products (Wegovy, Ozempic, Rybelsus). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

MedClub by Dr. Jenn

FDA issued a warning letter to MedClub by Dr. Jenn (Dr. Jenn Guthrie, MD) in West Palm Beach, FL, after reviewing the website drjennpb.com in June 2025 and finding it offered compounded retatrutide and semaglutide products. Compounded retatrutide was cited as an unapproved new drug and misbranded drug because retatrutide does not appear on the 503A or 503B bulks lists and is not a component of any FDA-approved drug. Compounded semaglutide products were cited as misbranded due to false or misleading claims including 'FDA Approved,' 'Generic Ozempic,' and 'USA Compounded'/'Custom Compounded,' which falsely implied equivalence to FDA-approved products. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

eDrugstore

FDA issued a warning letter to eDrugstore (Tempe, AZ) in September 2025 after reviewing its website and finding that marketing claims for compounded tirzepatide falsely implied the products were FDA-approved, in violation of FDCA sections 502(a) and 502(bb). Specific claims included labeling the active ingredient as 'FDA-Approved Active,' guaranteeing products are 'genuine, FDA-approved formulations,' and equating the compounded product with the brand-name drug Zepbound. FDA found these claims misbranded the products and directed eDrugstore to immediately cease using the offending language, with a written corrective response required within 15 working days, and warned that failure to comply could result in seizure or injunction.

SimpleRx

FDA issued a warning letter to SimpleRx (Bellevue, KY) in September 2025 after reviewing their website and finding that compounded semaglutide and tirzepatide products were marketed using brand names (Ozempic, Zepbound) in a manner that falsely implied equivalence to FDA-approved drugs. These claims were found to misbrand the compounded products under FDCA sections 502(a) and 502(bb). FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Las Villas Health Care LLC dba Villas Health

FDA issued a warning letter to Las Villas Health Care LLC dba Villas Health (Coral Gables, FL) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and sildenafil falsely implied equivalence to FDA-approved drugs (Ozempic/Wegovy and Viagra). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

GenLabMeds

FDA issued a warning letter to GenLabMeds, a telehealth/online pharmacy, in September 2025 after reviewing its website and finding it was selling compounded retatrutide, semaglutide, and tirzepatide products in violation of the FDCA. Retatrutide is not on the 503A or 503B bulks lists and is not an FDA-approved drug component, making GenLabMeds' compounded retatrutide products unapproved new drugs and misbranded drugs. Additionally, website claims falsely implied that compounded products were equivalent to or the same as FDA-approved branded drugs (e.g., Mounjaro, Zepbound, Ozempic, Wegovy). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

ybycmeds

FDA issued a warning letter to ybycmeds (Sanborn, NY) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound. The claims were found to misbrand the products under FDCA sections 502(a) and 502(bb), constituting prohibited interstate commerce under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Amazing Meds

FDA issued a warning letter to Amazing Meds (Colorado Springs, CO) in September 2025 after reviewing their website and finding they were selling compounded retatrutide and semaglutide products unlawfully. The compounded retatrutide products were cited as unapproved new drugs and misbranded drugs because retatrutide does not appear on the 503A or 503B bulks lists and is not a component of any FDA-approved drug. Additionally, Amazing Meds' claim that their compounded semaglutide is the 'same as Ozempic/Wegovy' was found to be false or misleading, rendering those products misbranded under FDCA sections 502(a) and 502(bb). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Lovely Meds, Inc. dba Lovely Meds

FDA issued a warning letter to Lovely Meds, Inc. dba Lovely Meds (Clarksville, MD) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved brand-name drugs (Wegovy, Ozempic, Zepbound, Mounjaro). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Dermacare LLC dba BlueChew

FDA's Center for Drug Evaluation and Research issued a warning letter to Dermacare LLC dba BlueChew in September 2025 after reviewing the bluechew.com website and finding that marketing claims for compounded sildenafil and tadalafil products falsely implied equivalence to FDA-approved drugs such as Viagra and Cialis. The agency determined these claims constitute misbranding under FDCA sections 502(a) and 502(bb) because compounded drugs are not FDA-approved and cannot lawfully be promoted as equivalent to approved products. FDA directed BlueChew to immediately cease using the offending language and to provide a written corrective response within 15 working days. Failure to comply could result in seizure or injunction without further notice.

Get.Fit.Medical, LLC dba Get.Fit.Medical

FDA issued a warning letter to Get.Fit.Medical, LLC on September 9, 2025, after reviewing its website and finding that the telehealth company marketed compounded sildenafil, tadalafil, semaglutide, and tirzepatide using brand-name equivalency claims such as 'GENERIC VIAGRA,' 'GENERIC OZEMPIC/WEGOVY,' and 'GENERIC MOUNJARO.' These claims falsely implied the compounded products were the same as FDA-approved drugs, constituting misbranding under FDCA sections 502(a) and 502(bb). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Chromatography Institute of America dba Compounder’s International Analytical Laboratory

FDA issued a warning letter to Chromatography Institute of America dba Compounder's International Analytical Laboratory (Castle Rock, CO), a contract testing laboratory serving 503B outsourcing facilities and other drug manufacturers, citing significant CGMP violations including inadequate laboratory controls, invalid sterility test investigations, and insufficient Quality Unit oversight. The firm was found to have adulterated drugs within the meaning of section 501(a)(2)(B) of the FD&C Act due to failures in microbiological testing, data integrity, and document control. FDA expressed concern about the validity and integrity of data provided to 503B outsourcing facilities and noted the firm communicated intent to shut down operations during the inspection. The letter warns that failure to remediate may result in seizure, injunction, withholding of export certificates, and blocking of new drug application approvals.

Exela Pharma Sciences, LLC

FDA issued a warning letter to Exela Pharma Sciences, LLC (Lenoir, NC) following a November 2024 inspection of its drug manufacturing and outsourcing facility, citing significant CGMP violations under 21 CFR parts 210 and 211. Key violations included inadequate investigation of out-of-specification and failing sterility/growth-promotion test results, inaccurate documentation of microbiology test results, and multiple deficiencies in sterility testing, stability programs, personnel training, and visual inspection programs for sterile compounded drug products. The facility had already deregistered as a 503B outsourcing facility in December 2024, but FDA warned that violations would apply if operations resume. FDA demanded written corrective actions within 15 working days and cautioned that failure to comply could result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.

Healwell Homeo Private Limited

FDA issued a warning letter to Healwell Homeo Private Limited, an Indian manufacturer of homeopathic and OTC drug products, following a December 2024 inspection that found pervasive insanitary conditions including live rodents, birds, rodent and avian excreta, mold, insects, and stray dogs in manufacturing and storage areas. The firm also failed to conduct identity testing on incoming components and lacked adequate quality unit oversight, written procedures, and process validation. FDA placed the firm on Import Alert 66-40, a distributor-initiated recall of U.S.-distributed products was executed in April 2025, and the firm is required to respond with corrective actions within 15 working days.

Staska Pharmaceuticals, Inc.

FDA issued a warning letter to Staska Pharmaceuticals, Inc. (Bennet, NE), a 503B outsourcing facility, following a September 2024 inspection that revealed serious CGMP deficiencies in sterile drug manufacturing, including insanitary aseptic conditions, inadequate media fills, and failed smoke studies. The facility also failed to meet 503B conditions by using bulk drug substances from an unregistered supplier and omitting required labeling elements (adverse event reporting info, directions for use) on products such as Glutathione Solution and Ascorbic Acid Solution. As a result, the compounded drug products are deemed adulterated, misbranded, and unapproved new drugs under the FDCA. FDA required a written response within 15 working days and strongly recommended a comprehensive third-party assessment of aseptic processing operations.

OSRX, Inc.

FDA issued a warning letter to OSRX, Inc., a registered 503B outsourcing facility in Missoula, Montana, following an October 2024 inspection that revealed sterile drug products were produced under insanitary conditions and failed to meet 503B labeling requirements. The facility's compounded sterile ophthalmic products were found adulterated due to inadequate smoke studies, unresolved microbial contamination in ISO 5 areas, and multiple CGMP violations including failures in aseptic process validation and environmental monitoring. The products were also deemed unapproved new drugs and misbranded due to missing adequate directions for use and incomplete labeling. FDA demanded a written corrective action response within 15 working days and warned that failure to comply may result in seizure or injunction.

Tailstorm Health Inc. dba Medivant Health

FDA issued a warning letter to Tailstorm Health Inc. dba Medivant Health (Phoenix, AZ), an outsourcing facility registered under section 503B, following a September–October 2024 inspection that found serious sterility and CGMP deficiencies. The facility's compounded drug products — including Semaglutide Injection, Tirzepatide Injection, and Bevacizumab — were found adulterated due to insanitary conditions, inadequate microbial contamination response, and deficient smoke studies, and were also deemed unapproved new drugs and misbranded. FDA demanded a written corrective action response within 15 working days and warned that failure to comply could result in seizure or injunction.

Empower Clinic Services, LLC dba Empower Pharmacy

FDA issued a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy (Houston, TX) following a September–October 2024 inspection that identified serious insanitary conditions in the production of sterile injectable drug products. Investigators found failures in environmental monitoring, inadequate media fills, and unsterilized equipment components contacting injectable drug product stoppers, rendering the compounded products adulterated under FDCA section 501(a)(2)(A). FDA found the firm's corrective action responses insufficient and lacking supporting documentation. The letter warns that failure to adequately address violations may result in seizure and injunction.

Advanced Pharmaceutical Technology

FDA issued a warning letter to Advanced Pharmaceutical Technology (Elmsford, NY) following a July–August 2024 inspection that found significant repeat CGMP violations at their combination product drug manufacturing facility. Key violations included failure to prevent microbiological contamination of purportedly sterile drug products, lack of adequate dissolution/release testing for controlled-release dosage forms, insufficient process validation, and an inadequate quality control unit that failed to oversee contract testing and manufacturing organizations. FDA warned that failure to correct these violations may result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals, and required a written response within 15 working days.

Annovex Pharma, Inc.

FDA issued a warning letter to Annovex Pharma, Inc. (Lorton, VA), a 503B outsourcing facility, following an August–September 2024 inspection that revealed serious CGMP violations and failure to meet section 503B conditions. The facility produced sterile drug products under insanitary conditions — including failing to investigate positive microbial growth in 10% of media fill units — and failed to submit required biannual drug product reports and adequate adverse event reporting procedures. As a result, the compounded drug products were deemed adulterated, misbranded, and unapproved new drugs, with FDA warning that failure to remediate may result in seizure or injunction.

ProRx, LLC

FDA issued an amended warning letter to ProRx, LLC, a 503B outsourcing facility in Exton, PA, following a July–August 2024 inspection that uncovered serious sterility assurance failures and CGMP violations in the production of sterile drug products including Semaglutide and Tirzepatide. The facility's compounded drugs were found to be adulterated due to insanitary conditions (e.g., insects in cleanrooms, improper gowning, no environmental monitoring in ISO 5 areas) and misbranded due to inadequate labeling and failure to meet 503B conditions. ProRx voluntarily recalled all sterile products within expiry on August 22, 2024, and ceased sterile production, but FDA found multiple corrective action responses deficient. FDA warned that failure to adequately address violations may result in seizure and injunction.

Strukmyer LLC dba Strukmyer Medical

FDA issued a warning letter to Strukmyer LLC dba Strukmyer Medical (Mesquite, TX) following a July–August 2024 inspection that found significant CGMP violations at their OTC drug manufacturing facility. The firm repeatedly isolated objectionable microorganisms (including Burkholderia and Pseudomonas) from their water system used to manufacture wound and burn products on over 60 occasions, failed to adequately investigate contamination incidents, and did not perform proper identity testing on high-risk components such as glycerin for DEG/EG contamination. FDA warned that failure to promptly correct these violations may result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals, and required a written response within 15 working days.

Nubratori, Inc. dba Nubratori Rx

FDA issued a warning letter to Nubratori, Inc. dba Nubratori Rx, a 503B outsourcing facility in Torrance, CA, following a July 2024 inspection that revealed serious CGMP deficiencies in sterile drug compounding operations. The violations included insanitary conditions (improper glove fingertip sampling), failure to establish adequate acceptance criteria for batch release, inadequate environmental monitoring, and failure to validate component supplier test analyses. FDA found the facility's corrective action responses insufficient due to missing supporting documentation, and warned that failure to adequately address violations may result in seizure or injunction.

Fagron Compounding Services, LLC dba Fagron Sterile Service

FDA issued a warning letter to Fagron Compounding Services, LLC dba Fagron Sterile Service, a 503B outsourcing facility in Wichita, KS, following a June 2024 inspection that found sterile drug products produced under insanitary conditions, CGMP violations, and labeling deficiencies that disqualified products from 503B exemptions. The facility's drug products were deemed adulterated (due to microbial contamination risks including a Chaetomium globosum recovery in an ISO 5 area and construction without adequate contamination controls), misbranded (lacking adequate directions for use), and unapproved new drugs. FDA acknowledged a voluntary recall of four lots of Lidocaine HCl Injection 2% for lack of sterility assurance and warned that failure to adequately address violations may result in seizure and injunction.

Brands International Corporation

FDA issued a warning letter to Brands International Corporation (Lakewood, NJ / Newmarket, Ontario) after a June 2024 inspection found the firm obstructed investigators, failed to adequately investigate mold contamination complaints, released drug products without proper active-ingredient testing, and stored APIs outdoors without climate control. The firm's drugs were deemed adulterated under multiple provisions of the FD&C Act, FDA placed the firm on Import Alert 66-40, and two voluntary recalls were initiated for mold-contaminated products. FDA demanded comprehensive corrective action plans, CGMP consultant engagement, and a written response within 15 working days.

Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals

FDA issued a warning letter to Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals, a 503B outsourcing facility in Irving, TX, following a May–June 2024 inspection that revealed adulterated sterile drug products, CGMP violations, and labeling deficiencies. The facility's compounded products—including Testosterone Cypionate injections and Ketoconazole cream—were found to be adulterated due to insanitary conditions and inadequate aseptic processing controls, and misbranded due to missing inactive ingredient information on labels. FDA determined the products do not qualify for 503B exemptions and are being marketed as unapproved new drugs, warning that failure to correct violations may result in seizure or injunction.

Choice All Natural, Inc. dba Om Botanical

FDA issued a warning letter to Choice All Natural, Inc. dba Om Botanical (Apex, NC) following a January–February 2024 inspection that found multiple CGMP violations including pest activity in raw material storage, inadequate finished-product release testing, lack of stability testing, and use of the QC laboratory for meal preparation. The company's 'Om Botanical Rash & Itch Cream' was cited as an unapproved new drug because its combination of Zinc Oxide, Witch Hazel, and Colloidal Oatmeal is not permitted under OTC Monograph M016, and the product was also found misbranded. Additionally, the firm's FDA establishment registration had lapsed since December 31, 2021, and five drug products were not listed with FDA. FDA warned that failure to correct violations may result in seizure, injunction, or withholding of export certificates and new application approvals.

Optikem International Inc.

FDA issued a warning letter to Optikem International Inc., a contract manufacturer of sterile OTC and homeopathic ophthalmic drug products in Denver, CO, citing significant CGMP violations found during a January 2024 inspection. Violations included inadequate aseptic processing facility design, insufficient environmental and personnel monitoring, lack of process simulation (media fills), failure to validate manufacturing and water systems, inadequate laboratory controls, and data integrity deficiencies. FDA also noted that certain ophthalmic drug products manufactured by Optikem are considered unapproved new drugs, and warned that failure to remediate could result in seizure, injunction, and withholding of export certificates or new application approvals.

Northern VA Compounders PLLC, dba Akina Pharmacy

FDA issued a warning letter to Northern VA Compounders PLLC dba Akina Pharmacy (Sterling, VA) following a November–December 2022 inspection that found serious insanitary conditions in sterile drug compounding operations, including use of non-pharmaceutical-grade sterilization materials, inadequate water quality controls, dirty aseptic processing equipment, and insufficient smoke studies for airflow validation. These deficiencies caused compounded drug products to be adulterated under section 501(a)(2)(A) of the FDCA. The pharmacy had already initiated a voluntary recall of all sterile lots produced using materials labeled 'research use only,' but FDA found the firm's corrective action responses lacked adequate supporting documentation. FDA warned that failure to adequately address violations may result in seizure or injunction.

Stokes Healthcare Inc. dba Epicur Pharma

FDA issued a warning letter to Stokes Healthcare Inc. dba Epicur Pharma, a 503B outsourcing facility in Mount Laurel, NJ, following a September–October 2023 inspection that revealed sterile drug products were produced under insanitary conditions and failed to meet CGMP requirements, rendering them adulterated under section 501(a)(2)(A) and (B) of the FDCA. Specific violations included inadequate sterilization testing, deficient media fills and smoke studies, insufficient sporicidal dwell times, and failure to investigate an adverse trend of Mucor circinelloides fungal contamination in ISO 8 cleanrooms while continuing to distribute affected drug products. The facility also failed to meet section 503B labeling conditions (missing inactive ingredient quantities and adverse event reporting information) and did not submit adverse event reports per 21 CFR 310.305, causing products to be misbranded. FDA demanded a written corrective action response within 15 working days and warned that failure to comply may result in seizure or injunction.

Central Admixture Pharmacy Services, Inc.

FDA issued a warning letter to Central Admixture Pharmacy Services, Inc. (CAPS Allentown), a 503B outsourcing facility, following a February–March 2023 inspection that found serious CGMP deficiencies and insanitary conditions in sterile drug compounding operations. The agency cited failures to adequately investigate microbial contamination in ISO 5 aseptic processing areas and deficient laboratory controls, rendering drug products adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B). CAPS had already initiated a voluntary recall of all sterile drug products within expiry on April 28, 2023, due to lack of sterility assurance. FDA warned that failure to adequately address violations may result in seizure and injunction, and noted similar CGMP deficiencies at sister facilities CAPS Phoenix and CAPS San Diego.

Central Admixture Pharmacy Services, Inc.

FDA issued a warning letter to Central Admixture Pharmacy Services, Inc. (CAPS Phoenix), a 503B outsourcing facility in Phoenix, AZ, following a June–July 2023 inspection that found serious CGMP deficiencies and insanitary conditions in sterile drug production. Investigators observed visibly dirty production areas, inadequate microbial contamination responses, failures in quality control, batch release testing, stability programs, and unauthorized electronic record access. The facility had already voluntarily recalled products and ceased production, but FDA found corrective action responses inadequate and lacking supporting documentation. FDA warned that failure to address violations may result in seizure or injunction, and required a written response within 15 working days.

LightEyez Limited

FDA issued a warning letter to LightEyez Limited (UK), the maker of MSM Eye Repair Drops and related ophthalmic products, after laboratory testing revealed gross microbial contamination (including Pseudomonas spp. and Mycobacterium spp.) in a batch of their eye drops. The products were also found to be unapproved new drugs under section 505(a) of the FD&C Act, with website claims asserting the drops could repair eyes, reduce glaucoma/cataracts, permanently change eye color by destroying melanin, and treat floaters and bloodshot eyes. FDA demanded a voluntary recall of all sterile products, full contamination investigations, and a written response within 15 working days, and warned that continued violations could result in refusal of admission of LightEyez products into the United States.

Amman Pharmaceutical Industries

FDA issued a warning letter to Amman Pharmaceutical Industries, a Jordanian contract manufacturer of sterile OTC and homeopathic drug products, following an August 2023 inspection that revealed serious CGMP violations including fundamental aseptic processing design flaws, inadequate environmental monitoring, pervasive data integrity breaches, and an ineffective quality control unit. The facility had shipped sterile drug products to the U.S. without completing required process simulations (media fills) or dynamic smoke studies, and laboratory records were found to be unreliable with over 50 microbial excursions contradicting the firm's claim of zero excursions over two years. FDA placed the firm on Import Alert 66-40, the firm committed to recalling all U.S.-bound drug products and suspending production, and FDA warned that failure to remediate could result in seizure, injunction, and continued refusal of admission of articles into the United States.

Madhu Instruments Private Limited

FDA issued a warning letter to Madhu Instruments Private Limited (New Delhi, India) following a 2022 inspection that found sterile drug products manufactured under insanitary conditions, including peeling paint, blocked HEPA filters, broken tiles with residue, visibly dirty equipment, and improvised patching materials in ISO 7 manufacturing rooms. The firm's corrective response was deemed inadequate for failing to conduct a retrospective risk assessment or develop a sufficient cleaning and sanitization regimen. FDA had already placed the firm on Import Alert 66-40 as of May 31, 2023, subjecting its products to detention or refusal of admission into the United States. The letter requires a written response within 15 working days with documented corrective actions.

Les Importations Herbasanté Inc.

FDA issued a warning letter to Les Importations Herbasanté Inc., a Canadian contract manufacturer of homeopathic drug products (including pediatric formulations), following an August 2023 inspection that revealed significant CGMP violations. The firm failed to perform adequate identity testing of high-risk components such as glycerin (which carries risk of lethal diethylene glycol/ethylene glycol contamination), failed to validate its manufacturing processes, and had an inadequate quality control unit. As a result, FDA placed the firm on Import Alert 66-40, making its products subject to detention or refusal of admission into the United States, and required corrective action within 15 working days.

QuVa Pharma, Inc.

FDA issued a warning letter to QuVa Pharma, Inc., a 503B outsourcing facility in Bloomsbury, NJ, following an August–October 2022 inspection that revealed serious sterility and CGMP deficiencies in the production of sterile drug products. Investigators observed mold recovery on operator glove finger plate samples in ISO 5 areas, improper aseptic technique by operators, and multiple CGMP violations including inadequate environmental monitoring, failure to investigate batch discrepancies, and inadequate computer system controls. The facility had already initiated a voluntary recall of oxytocin product due to incorrect formulation, and FDA warned that failure to adequately address violations may result in seizure and injunction.

Colonial Dames Company, Ltd

FDA issued a warning letter to Colonial Dames Company, Ltd (Commerce, CA) following a April 2023 inspection that found significant CGMP violations and unapproved new drug marketing for its 'oxygenetix® Oxygenating Foundation Acne Control' and a redacted companion product. The products were marketed with drug claims—including acne treatment, anti-inflammatory, antimicrobial, and time-release salicylic acid efficacy claims—without FDA approval and in non-conformance with the OTC Topical Acne Monograph M006. The facility also had repeat CGMP deficiencies (unclean equipment, unvalidated processes, inadequate quality unit oversight) dating back to 2015 inspections, and failed to properly list the drug products with FDA. FDA warned that failure to correct violations may result in seizure, injunction, or withholding of export certificates and new application approvals.

Sun Pharmaceutical Industries Ltd.

FDA issued an amended warning letter to Sun Pharmaceutical Industries Ltd. (Halol, India) following a May 2022 inspection that found significant CGMP violations including inadequate media fills, poor aseptic technique, contaminated and damaged filling equipment, and insufficient contamination investigations. The violations affected sterile injectable products including medroxyprogesterone acetate injectable suspension and testosterone cypionate injection, with multiple voluntary recalls initiated. FDA placed the firm on Import Alert 66-40 and warned that continued non-compliance could result in refusal of admission of articles into the United States.

Southern Tier Home Infusion, Inc. dba Pharmacy Innovations

Southern Tier Home Infusion, Inc. dba Pharmacy Innovations, a compounding pharmacy in Erie, PA, received an FDA Warning Letter following a November 2022 inspection that found sterile drug products produced under insanitary conditions, including rust, microbial contamination, inadequate HEPA filtration, and poor aseptic operator practices. The firm also compounded drug products — including Lidocaine/Tetracaine/Phenylephrine 20/4/2% Gel and Dutasteride 0.1% Injectable — without valid patient-specific prescriptions, disqualifying them from section 503A exemptions and rendering them unapproved new drugs and misbranded products. FDA acknowledged the firm's voluntary recall of all sterile compounded products and cessation of sterile compounding in the affected area, but found several corrective action responses insufficient. The letter warns that failure to adequately address violations may result in seizure or injunction.

Curexa – East, LLC dba Curexa

FDA issued a warning letter to Curexa – East, LLC dba Curexa (Egg Harbor Township, NJ) following an August–September 2022 inspection that found serious insanitary conditions in the compounding pharmacy's production area, including non-microbial contamination, inadequate cleaning of utensils and equipment used for hazardous drugs, and residue buildup in air-handling equipment directly above production areas. These conditions rendered the firm's compounded drug products adulterated under section 501(a)(2)(A) of the FDCA. FDA found the firm's corrective-action responses to the Form FDA 483 either insufficiently documented or outright deficient, and warned that failure to adequately address violations may result in seizure or injunction.

Similasan AG

FDA issued a warning letter to Similasan AG, a Swiss homeopathic ophthalmic drug manufacturer, citing that twelve named eye-drop and gel products sold in the U.S. are unapproved new drugs lacking FDA approval under FD&C Act section 505(a). The letter also identifies serious CGMP violations including inadequate aseptic process validation, failure to conduct 100% visual inspection for particulates, incomplete laboratory records, and insufficient quality unit oversight. FDA placed all Similasan AG products on Import Alert 66-40, and the agency warned that continued violations may result in seizure, injunction, and detention of products without physical examination. The company was directed to respond within fifteen working days with corrective actions.

US Specialty Formulations, LLC

FDA issued a warning letter to US Specialty Formulations, LLC, a 503B outsourcing facility in Allentown, PA, following a March–April 2022 inspection that revealed serious sterility assurance failures, CGMP violations, and labeling deficiencies. The facility's compounded sterile drug products were found to be adulterated due to insanitary conditions (e.g., use of non-sterile wipes in ISO 5 areas, inadequate aseptic technique, insufficient environmental monitoring) and multiple CGMP regulatory violations. Because the products failed to meet 503B conditions, they are also deemed unapproved new drugs and misbranded, and FDA warned that failure to remediate could result in seizure or injunction.

Denison Pharmaceuticals, LLC

FDA issued a warning letter to Denison Pharmaceuticals, LLC (Lincoln, RI) following a January–February 2023 inspection that found significant CGMP violations including inadequate contamination investigations, failure to test for DEG/EG in high-risk components, and use of unvalidated microbiological test methods. Additionally, FDA determined that three homeopathic products — 'Colic Calm,' 'Colic Calm +,' and 'Nauzene Kids' — are unapproved new drugs based on disease-treatment claims on their labels and associated websites. The company issued a voluntary nationwide recall of four products in May 2023, and FDA warned that failure to correct violations could result in seizure, injunction, and withholding of approvals.

Pharmacy Plus, Inc., dba Vital Care Compounder

FDA issued a warning letter to Pharmacy Plus, Inc., dba Vital Care Compounder (Hattiesburg, MS) following an October 2022 inspection that found serious insanitary conditions in sterile drug compounding operations, including microbial contamination in ISO 5 aseptic processing areas, use of non-sterile materials, inadequate media fills, and insufficient smoke studies. The firm had already initiated a voluntary recall of sterile drug products within expiry on October 7, 2022, but FDA found the corrective action responses incomplete and lacking supporting documentation. FDA cited violations of FDCA section 501(a)(2)(A) (adulterated drugs under insanitary conditions) and warned that failure to adequately address violations may result in seizure or injunction. The firm was required to respond within 15 working days with specific corrective steps and supporting documentation.

ImprimisRx NJ

FDA issued a warning letter to ImprimisRx NJ (President John Saharek) following a July–August 2022 inspection that revealed serious insanitary conditions in sterile drug compounding operations and repeated release of subpotent Timolol-Latanoprost ophthalmic drops. The facility's drug products were deemed adulterated under FDCA sections 501(a)(2)(A) and 501(c) due to insanitary cleanroom conditions and label-strength discrepancies, and misbranded under section 502(a) for false labeling. This was a repeat issue, as subpotency of the same product was also identified during a 2019 inspection. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Carolina Infusion

FDA issued a warning letter to Carolina Infusion (Ridgeland, SC), a compounding pharmacy owned by Melissa Etheridge, following a July–August 2022 inspection that found drug products produced without valid patient-specific prescriptions, insanitary sterile compounding conditions (including inadequate endotoxin testing, improper cleanroom pressure differentials, and uncertified ISO-5 hoods), and use of non-pharmaceutical-grade components. The firm's compounded products — including Tri-Mix 30/2/20 Injectable and topical anesthetics — were deemed adulterated, misbranded, and unapproved new drugs under the FDCA. FDA demanded a written corrective-action response within 15 working days and warned that failure to comply could result in seizure or injunction.

Champaklal Maganlal Homeo Pharmacy Private Limited

FDA issued a warning letter to Champaklal Maganlal Homeo Pharmacy Private Limited (India) and its U.S. distributor Pharmadel, LLC/CAD Import, Inc. for manufacturing and distributing 'Bebelyn Diarrhea' and 'Bebelyn Colic' — homeopathic drug products marketed for infants and young children — without FDA approval. The products were found to be unapproved new drugs under section 505(a) of the FD&C Act, and the manufacturer had previously been cited for CGMP violations including failure to adequately test glycerin for diethylene glycol contamination, a known lethal hazard. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

New England Life Care, Inc. dba Advanced Compounding Solutions

FDA issued a warning letter to New England Life Care, Inc. dba Advanced Compounding Solutions, a 503B outsourcing facility in Woburn, MA, following a March–April 2022 inspection that revealed serious CGMP violations and insanitary conditions in sterile drug production. The facility's compounded drug products — including Diltiazem HCl, Norepinephrine Bitartrate, Vancomycin HCl, and Phenylephrine HCl preparations — were found to be adulterated due to insanitary conditions (pest intrusion, blocked air returns, improper aseptic technique) and CGMP failures (inadequate investigations, complaint handling, sterilization validation, and cleaning procedures). Products also failed to meet 503B labeling conditions (missing dosage form on labels), rendering them ineligible for exemptions from FDA approval and adequate-directions-for-use requirements. FDA warned that failure to adequately address violations may result in seizure and injunction.

Pharmedica USA, LLC

FDA issued a warning letter to Pharmedica USA, LLC (Phoenix, AZ) following a November 2022 inspection that found the company manufactured preservative-free, multi-dose ophthalmic eye drops and nasal spray products under insanitary conditions without ISO-classified sterile manufacturing areas, no sterility testing, no process validation, and no adequate quality unit. The violations rendered the drug products adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FD&C Act. The company voluntarily ceased all drug manufacturing and distribution, and on March 3, 2023 issued a worldwide recall of Purely Soothing 15% MSM Drops due to non-sterility. FDA warned that failure to address violations could result in seizure, injunction, and withholding of export certificates or new application approvals.

Champaklal Maganlal Homeo Pharmacy Private Limited

FDA issued a warning letter to Champaklal Maganlal Homeo Pharmacy Private Limited (India) for significant CGMP violations identified through a 704(a)(4) records request. The firm failed to conduct adequate identity testing on glycerin — a high-risk component used in OTC and homeopathic drug products — specifically to detect potentially lethal diethylene glycol (DEG) and ethylene glycol (EG) impurities. FDA placed all drugs manufactured by the firm on Import Alert 66-40 as of March 3, 2023, meaning products may be detained or refused admission at the U.S. border. The firm was directed to conduct risk assessments, test retain samples, and engage a CGMP consultant before resuming U.S. market manufacturing.

Chemical Services Group, Inc./Royal Chemical Company

FDA issued a warning letter to Chemical Services Group, Inc./Royal Chemical Company (Macedonia, OH / East Stroudsburg, PA) following a November 2022 inspection of their drug manufacturing facility. The agency found significant CGMP violations including manufacturing OTC hand sanitizer drug products on equipment shared with industrial chemicals, failure to validate ethanol supplier test analyses, inadequate batch release testing (missing methanol and benzene impurity checks), and a quality control unit that failed to exercise proper oversight. FDA warned that failure to correct these violations could result in seizure, injunction, or withholding of export certificates and new drug application approvals.

Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy

FDA issued a warning letter to Belmar Pharma Solutions / Drug Depot, LLC dba APS Pharmacy (Palm Harbor, FL) following a June 2022 inspection, finding that the compounding pharmacy produced drug products using bulk drug substances ineligible under section 503A of the FDCA — specifically substances lacking USP/NF monographs, not components of FDA-approved drugs, and not on the 503A bulks list — and sourced from unregistered establishments. As a result, the compounded products were deemed unapproved new drugs and misbranded under sections 505 and 502(f)(1) of the FDCA. FDA warned that continued non-compliant compounding could result in seizure and injunction, and required a written corrective-action response within 15 working days.

Atlantic Management Resources LTD dba. Claire Ellen Products

FDA issued a warning letter to Atlantic Management Resources LTD dba Claire Ellen Products (Westborough, MA) following a July–August 2022 inspection that found significant CGMP violations in the manufacture of homeopathic drug products, including failure to establish a quality unit, inadequate storage conditions, and absence of batch production records. The firm also distributed 'Neuroquell Plus Cream' without proper FDA drug listing, rendering it misbranded. The company voluntarily ceased production and distribution and issued a nationwide recall in November 2022. FDA warned that failure to address violations could result in seizure, injunction, or withholding of approvals, and required a written response within 15 working days.

Green Pharmaceuticals Inc.

FDA issued a warning letter to Green Pharmaceuticals Inc. (Camarillo, CA) regarding its OTC homeopathic nasal spray product SnoreStop NasoSpray, which was found to be adulterated with gross microbial contamination (Providencia rettgeri, with counts up to 6,200 CFU/mL) and manufactured without adequate CGMP controls. The product was also found to be an unapproved new drug under section 505 of the FD&C Act, as its labeling made drug-use claims without an FDA-approved application. A voluntary recall of the contaminated lot was conducted in June 2022, and FDA warned that failure to correct violations could result in seizure, injunction, and withholding of approvals.

Optum Infusion Services 308 LLC

FDA issued a warning letter to Optum Infusion Services 308 LLC (Chandler, AZ) following a March 2022 inspection that found serious insanitary conditions in its sterile compounding operations, including vermin in the production area, microbial contamination in the ISO 5 aseptic processing zone, and improper aseptic technique by operators. These conditions rendered the facility's sterile drug products adulterated under section 501(a)(2)(A) of the FDCA. FDA found the facility's corrective action responses inadequate due to missing supporting documentation and directed the firm to respond within 15 working days, warning that failure to comply could result in seizure or injunction.

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

FDA issued a warning letter to North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding (Richardson, TX) following a March 2022 inspection that identified serious insanitary conditions in sterile drug compounding operations. Violations included inadequate sterilization equipment, insufficient disinfection procedures, improper handling of hazardous drugs, failed smoke studies, and inadequate media fills — all causing drug products to be adulterated under section 501(a)(2)(A) of the FDCA. The firm had already initiated a voluntary recall of sterile drug products in April 2022. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC

FDA issued a warning letter to Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC, a registered 503B outsourcing facility in West Columbia, SC, following a March–April 2022 inspection that revealed serious sterility assurance failures, including approximately 1,686 microbial contamination excursions in ISO 5 aseptic processing areas and inadequate media fills. The facility also compounded drug products using glycopyrrolate, a bulk drug substance not on the 503B bulks list and not on the drug shortage list, rendering those products ineligible for 503B exemptions and subject to unapproved new drug and misbranding violations. FDA acknowledged two voluntary recalls initiated by the firm but found corrective action responses inadequate in several respects. The letter warns that failure to address violations may result in seizure and injunction.

Nephron SC Inc.

FDA issued a warning letter to Nephron SC Inc. (West Columbia, SC) following a March–April 2022 inspection that found significant CGMP violations at its drug manufacturing facility. The agency cited failures to adequately investigate cross-contamination of drug products (including Bupivacaine detected in other drug lots), inadequate response to microbial contamination (Pseudomonas aeruginosa) in aseptic processing, deficient environmental monitoring in ISO 5 critical areas, and a failure to submit required NDA Field Alert Reports within three working days of identifying contamination — waiting over a year to file. FDA warned that failure to remediate may result in seizure, injunction, withholding of export certificates, and denial of new application approvals.

Sterling Pharmaceutical Services, LLC

Sterling Pharmaceutical Services, LLC, a contract manufacturer of sterile ophthalmic drug products in Dupo, Illinois, received an FDA Warning Letter citing significant CGMP violations including inadequate investigation of microbiological contamination in aseptic processing areas, insufficient environmental monitoring, and poor aseptic practices by personnel. The FDA also found that multiple sterile eye drop and ointment products bearing therapeutic claims (including homeopathic ophthalmic products) were unapproved new drugs marketed without FDA-approved applications in violation of sections 301(d) and 505(a) of the FD&C Act. The letter warns that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications.

Vita Pharmacy, LLC dba Talon Pharmacy of Boerne

FDA issued a warning letter to Vita Pharmacy, LLC dba Talon Pharmacy of Boerne (co-owner Praful Patel) following an October–November 2021 inspection that revealed serious insanitary conditions in sterile drug compounding operations. Violations included inadequate air-quality separation between ISO-classified areas, failure to segregate hazardous drug production, visibly dirty equipment with unknown foreign substances on HEPA filters, inadequate disinfection protocols, missing smoke studies, and insufficient aseptic process simulations (media fills). FDA found the firm's corrective-action responses deficient in multiple respects and warned that failure to adequately address violations may result in seizure or injunction.

Sagent Pharmaceuticals, Inc.

FDA issued a warning letter to Sagent Pharmaceuticals, Inc. (SterRx, LLC) following a September–November 2021 inspection of its 503B outsourcing facility in Plattsburgh, NY, finding serious CGMP deficiencies in sterile drug manufacturing, including inadequate first-air protection, turbulent ISO 5 airflow, microbial contamination failures, dirty equipment, and improper sterilization practices. These deficiencies caused drug products to be adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FDCA. The firm had already voluntarily ceased aseptic production, initiated a voluntary recall of sterile lots, and destroyed in-process inventory, but FDA found corrective action responses inadequate due to missing supporting documentation. FDA warned that failure to adequately address violations may result in seizure or injunction, and required a written response within 15 working days.

Imprimis Rx LLC

FDA issued a warning letter to Imprimis Rx LLC (Carlsbad, CA) regarding promotional materials for its compounded ophthalmic drug product Pred-Moxi-Brom (PMB), published in two professional periodicals in early 2021. The agency found the materials made false or misleading claims about FDA approval status (implying bulk drug substances were FDA-approved), unsubstantiated superiority claims over other drug products, and misleading safety presentations that omitted known risks of the active ingredients. FDA cited violations of 21 U.S.C. 352(bb), 321(n), and 331(a) and demanded written corrective action within 15 working days, warning that failure to comply may lead to further regulatory action.

Fagron Group B.V.

FDA issued a warning letter to Fagron Group B.V. (via its Saint Paul, Minnesota facility) following a November 2021 inspection that found significant CGMP deviations in the repackaging and relabeling of active pharmaceutical ingredients, including testosterone, estradiol, and opioids. Key violations included failure to conduct adequate cleaning validation to prevent cross-contamination, failure to investigate out-of-specification results, and failure of the quality unit to exercise proper oversight including unrestricted data deletion on CGMP-related equipment. FDA warned that failure to correct these deviations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications.

Hybrid Pharma, LLC

FDA issued a warning letter to Hybrid Pharma, LLC, a 503B outsourcing facility in Deerfield Beach, FL, following a July–September 2021 inspection that revealed CGMP violations, failure to submit complete drug product reports, and production of adulterated, misbranded, and unapproved new drug products. The facility failed to thoroughly investigate batch discrepancies, establish validated test methods, and maintain adequate environmental monitoring for aseptic processing. Drug products including Phosphatidyl choline 5% and deoxycholate 4.2% injectable were compounded without meeting 503B conditions, rendering them ineligible for exemptions from FDA approval requirements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

New Vitalis, LLC dba New Vitalis Pharmacy

FDA issued a warning letter to New Vitalis, LLC dba New Vitalis Pharmacy (Louisville, KY) following an August 2021 inspection that found serious insanitary conditions in its sterile compounding operations, including vermin near production areas, dirty surfaces, improper aseptic technique, and unsealed HEPA filters. These deficiencies caused drug products — including Testosterone Cypionate/Testosterone Propionate — to be adulterated under section 501(a)(2)(A) of the FDCA. The firm had already voluntarily recalled the affected testosterone products and ceased all sterile compounding by September 7, 2021. FDA warned that failure to adequately address violations may result in seizure and injunction, and required a written response within 15 working days.

Age Management Institute Santa Barbara

FDA issued a warning letter to Age Management Institute Santa Barbara (owner Michael R. Repik, D.O.) following a March–April 2021 inspection that found serious sterile compounding deficiencies, including lack of a certified ISO 5 area, visibly dirty equipment and surfaces, and use of expired components in IV therapy drug products. These conditions rendered the compounded drug products adulterated under section 501(a)(2)(A) of the FDCA. The facility had voluntarily ceased IV therapy drug production at the time of inspection. FDA warned that failure to adequately address violations may result in seizure and injunction, and required a written response within 15 working days.

Med Shop Total Care, Inc.

FDA issued a warning letter to Med Shop Total Care, Inc. (Longview, TX), a compounding pharmacy, following a July 2021 inspection that identified serious insanitary conditions in sterile drug production. Violations included microbial contamination in the ISO 5 aseptic processing area, improper glove sanitization, inadequate disinfectant contact times, and a brownish residue on a HEPA filter screen — all causing drug products to be adulterated under FDCA section 501(a)(2)(A). The firm's corrective action responses were deemed inadequate in key areas, and FDA warned that failure to remediate could result in seizure or injunction.

Dr Retter Ec Wladyslaw Retter

FDA issued a CGMP warning letter to Dr Retter Ec Wladyslaw Retter, a Polish OTC drug manufacturer, citing four significant violations related to manufacturing a homeopathic cream distributed to the United States: lack of process validation (including a ~100,000,000-fold discrepancy in active ingredient concentration versus label claims), failure to conduct identity testing on incoming components, inadequate batch production records, and insufficient laboratory controls for microbiological testing. FDA placed all products from the firm on Import Alert 66-40 as of March 4, 2022, and warned that continued non-compliance may result in refusal of admission of all articles manufactured at the facility into the United States.

Sanitor Corporation

FDA issued a warning letter to Sanitor Corporation (Stanton, CA) following a May–June 2021 inspection that found multiple CGMP violations including inadequate quality control, microbial contamination in hand sanitizer batches, data integrity failures, and distribution of drug products before testing was complete. The company also marketed unapproved new drug products — hydroquinone-based skin bleaching/lightening products — without FDA approval, and one acne product was found to be misbranded for failing to bear a required statement of identity. FDA warned that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications.

Empower Clinic Services, LLC dba Empower Pharmacy

FDA issued a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy (Houston, TX), an outsourcing facility registered under section 503B, following a February–March 2020 inspection. The facility failed to meet multiple 503B conditions, including omitting required adverse event reporting contact information from drug product labels (e.g., Testosterone Cypionate, HCG, FSH, Menotropins), failing to submit complete biannual drug compounding reports, maintaining inadequate adverse event reporting procedures, and wholesaling compounded drugs through a third-party entity in violation of the prohibition on wholesaling. Because these conditions were not met, the compounded products are deemed unapproved new drugs and misbranded under the FDCA, and FDA warned that failure to correct violations may result in seizure or injunction.

Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop

FDA issued a warning letter to Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop, a 503B-registered outsourcing facility in Texas, following a 2019 inspection. The facility failed to meet section 503B conditions by omitting National Drug Code numbers from labels (including Estradiol and Testosterone pellets), failing to report all compounded drug products upon initial registration, and submitting an adverse event report 35 days late for a serious event involving testosterone pellets. As a result, the compounded drug products were deemed unapproved new drugs and misbranded, with FDA warning that continued non-compliance could result in seizure and injunction.

Walfer Corporation dba The Medicine Shoppe Pharmacy

FDA issued a warning letter to Walfer Corporation dba The Medicine Shoppe Pharmacy (Port Charlotte, FL) following a March 2020 inspection that found the compounding pharmacy producing drug products without valid patient-specific prescriptions, under insanitary conditions (vermin, stained equipment, unsealed ceiling tiles), and in violation of CGMP regulations. The facility also compounded what appeared to be essentially copies of commercially available drug products (e.g., Oxycodone HCl 30mg capsules). FDA found the drug products adulterated and misbranded under the FDCA, and the firm had already recalled all in-expiry products and ceased sterile compounding. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Infusion Options, Inc.

FDA issued a warning letter to Infusion Options, Inc. (Brooklyn, NY), an outsourcing facility registered under section 503B, following a 2019 inspection that found sterile drug products produced under insanitary conditions, multiple CGMP violations, missing required labeling elements, and failure to submit mandatory biannual drug product reports to FDA. The compounded drug products were deemed adulterated under section 501(a)(2)(A) and (B) and misbranded under section 502(f)(1) of the FDCA. The facility had already voluntarily recalled all sterile products, permanently discontinued 503B compounding, and de-registered as an outsourcing facility prior to the letter. FDA required written acknowledgment within 15 working days and warned that failure to address violations could result in seizure or injunction.

AnazaoHealth Corporation

FDA issued a warning letter to AnazaoHealth Corporation, a Las Vegas-based 503B outsourcing facility, following a September 2019 inspection. The agency found that the facility's compounded drug products failed to meet section 503B conditions—specifically due to inadequate adverse event reporting procedures—rendering them ineligible for exemptions from FDA approval and labeling requirements. As a result, the products were deemed unapproved new drugs and misbranded under the FDCA. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Maitland Labs of Central Florida

FDA issued a warning letter to Maitland Labs of Central Florida (Orlando, FL), a registered 503B outsourcing facility, following a February 2020 inspection that revealed serious CGMP deficiencies and labeling violations. The facility's compounded sterile drug products — including Nalbuphine HCl 10 mg/mL in 0.2% Saline — were found to be adulterated, misbranded, and marketed as unapproved new drugs, failing to meet the conditions of section 503B necessary for exemptions from FDA approval requirements. Specific violations included failure to investigate batch discrepancies, inadequate stability testing, failure to conduct sterility/pyrogen testing, false ingredient concentration on labels, and incomplete storage/handling instructions. FDA warned that continued non-compliance could result in seizure and injunction, and required a written response within 15 working days.

Pharmaceutical Care Solutions dba Pharmacy Solutions

FDA issued a warning letter to Pharmaceutical Care Solutions dba Pharmacy Solutions (Ann Arbor, MI) following a January 2020 inspection, finding that the compounding pharmacy produced drug products ineligible for section 503A exemptions by using ammonium tetrathiomolybdate — a bulk drug substance not on the 503A bulks list, not USP/NF monograph-compliant, and not a component of an FDA-approved drug — and by sourcing bulk drug substances from an unregistered manufacturer. As a result, the compounded products were deemed unapproved new drugs and misbranded under the FDCA. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Farmakeio Outsourcing LLC

FDA issued a warning letter to Farmakeio Outsourcing LLC (Southlake, TX), a 503B-registered outsourcing facility, following a 2019 inspection that found the facility's compounded drug products failed to meet section 503B conditions. Key violations included inadequate adverse event reporting procedures, compounding testosterone pellets that may constitute essentially a copy of an approved drug (Testopel), and distributing unapproved new drugs and misbranded products lacking adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Matthew 7:25 Inc dba Thrive Pharmacy

FDA issued a warning letter to Matthew 7:25 Inc dba Thrive Pharmacy (Jacksonville, FL) after a December 2019 inspection found the compounding pharmacy failed to meet section 503A conditions, including compounding drug products without valid patient-specific prescriptions (e.g., phentermine 37.5 mg capsules for office stock). FDA laboratory analysis confirmed that three buprenorphine/naloxone troche products were subpotent relative to their labeled concentrations, rendering them adulterated and misbranded under the FDCA. The pharmacy had already initiated a voluntary recall of the affected troches in March 2020, but FDA found corrective actions incomplete and warned that failure to address violations could result in seizure or injunction.

MasterPharm LLC

FDA issued a warning letter to MasterPharm LLC (South Richmond Hill, NY) following a May–June 2020 inspection that revealed serious manufacturing deficiencies at the compounding pharmacy. The firm's Finasteride Plus capsules were found to contain super-potent finasteride (1.49 mg vs. labeled 1.25 mg) and undeclared minoxidil at 127.86 mg per capsule, triggering 74 adverse-event MedWatch reports and a voluntary recall. FDA cited the drug products as both adulterated (insanitary conditions, cross-contamination, incorrect strength, undeclared ingredient) and misbranded (false/misleading labeling), and warned that failure to correct violations could result in seizure or injunction.

Joe Wise Pharmacy, Inc., dba Wise Pharmacy

FDA issued a warning letter to Joe Wise Pharmacy, Inc. dba Wise Pharmacy (Littleton, CO) following a June 2019 inspection that found serious insanitary conditions in the production of sterile and non-sterile drug products. Violations included operating an ISO 5 workstation in a non-classified room, inadequate cleaning of hazardous drug hoods, failure to perform proper smoke studies, and deficient environmental monitoring — all causing drug products to be adulterated under FDCA section 501(a)(2)(A). The firm had already voluntarily recalled all sterile products and ceased sterile compounding as of July 10, 2019, but FDA found the corrective actions incomplete and warned that failure to fully remediate could result in seizure or injunction.

Exela Pharma Sciences LLC

FDA issued a warning letter to Exela Pharma Sciences LLC, a registered 503B outsourcing facility in Lenoir, NC, after a 2019 inspection found that its compounded drug products failed to meet the conditions of section 503B of the FDCA — specifically due to inadequate adverse event reporting procedures that did not reference the required Safety Reporting Portal or Electronic Submission Gateway. Because the 503B conditions were not met, the compounded drugs were deemed unapproved new drugs and misbranded products subject to full FDCA requirements. FDA demanded a written corrective action response within 15 working days and warned that failure to comply could result in seizure and injunction.

American Specialty Pharmacy, Inc. dba ASP Cares

FDA issued a warning letter to American Specialty Pharmacy, Inc. dba ASP Cares (Farmers Branch, TX), an outsourcing facility registered under section 503B of the FDCA, following a 2018 inspection that revealed serious sterile manufacturing deficiencies and failure to meet 503B conditions. The facility produced adulterated drug products due to insanitary conditions and CGMP violations including inadequate smoke studies, deficient media fills, facility disrepair, and failure to document pressure differentials. Because the facility failed to comply with adverse event reporting requirements under 503B(b)(5), its compounded products lost eligibility for exemptions from FDA approval, adequate-directions-for-use labeling, and Drug Supply Chain Security Act requirements, rendering them unapproved new drugs and misbranded products. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Maison Terre, LLC

FDA issued a warning letter to Maison Terre, LLC (owner Sarah A. Brown) for repackaging and selling 'Goldenseal Root Powder Organic' under insanitary conditions — including in a residential kitchen and living room — resulting in dangerous microbial contamination (including Cronobacter sakazakii and Klebsiella pneumoniae) linked to at least one infant death. The products were found to be unapproved new drugs and misbranded under the FD&C Act, and the firm also marketed essential oils ('Orange (Sweet) Essential Oil' and 'Ylang Ylang 3 Essential Oil') with unapproved drug claims. FDA demanded a written response within 15 working days and warned that failure to correct violations could result in seizure or injunction.

Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy

FDA issued a warning letter to Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy (Kona Community Hospital Pharmacy, Kealakekua, HI) following a December 2019 inspection that found serious insanitary conditions in sterile drug compounding operations, including repeated microbial contamination in cleanrooms, deficient facility design, inadequate smoke studies, and use of a non-sterile disinfectant in aseptic processing areas. These conditions caused the compounded sterile drug products to be adulterated under section 501(a)(2)(A) of the FDCA. The pharmacy's corrective action responses were deemed insufficient due to lack of supporting documentation. FDA warned that failure to promptly correct violations may result in seizure and injunction, and required a written response within 15 working days.