Peptide

GenoGenix LLC

GenoGenix LLC, a compounding outsourcing facility in Boca Raton, FL, received an FDA Warning Letter following a July 2025 inspection that uncovered pervasive CGMP violations, sterility failures, and use of ineligible bulk drug substances including 5-Amino-1MQ, NAD+, and Thymosin Beta-4. The facility also repackaged unapproved new drugs including Semaglutide, Tirzepatide, and Retatrutide without FDA-approved applications, and released products with sub-labeled potency and excessive bacterial endotoxins that sent three patients to the emergency room. FDA required a written response within 15 working days and warned that failure to adequately address violations may result in seizure and injunction; the firm had already voluntarily ceased production and initiated a recall.

Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS

FDA issued a warning letter to Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS (Madison, WI) for marketing SARMs products — 'GE Labs Ykarine' and 'GE Labs MK 677' — as dietary supplements on their websites. The products were found to be unapproved new drugs under the FD&C Act, and lab analysis confirmed 'GE Labs Ykarine' contained undeclared trendione, a Schedule III controlled anabolic steroid, rendering it misbranded. FDA cited serious safety concerns including liver toxicity, heart attack, stroke, and kidney damage associated with SARMs and anabolic steroids. The firm was directed to respond within 15 working days with corrective steps, and warned that failure to comply may result in seizure or injunction.

Pinnacle Professional Research dba Pinnacle Peptides

FDA issued a warning letter to Pinnacle Professional Research dba Pinnacle Peptides (Greensboro, NC) in December 2025 after reviewing their website and finding three SARM products — S4 Andarine, LGD-4033, and MK-2866 — marketed with drug-intended-use claims including treatment of cancer, osteoporosis, muscle wasting, and diabetes. Despite 'FOR RESEARCH ONLY / NOT FOR HUMAN USE' disclaimers, FDA determined the website copy established human drug intent, rendering the products unapproved new drugs in violation of FD&C Act sections 301(d) and 505(a). The letter demands a written corrective-action response within 15 working days and warns that failure to comply may result in seizure or injunction.

Darmerica, LLC

FDA issued a warning letter to Darmerica, LLC (Davie, FL), an API distributor and repackager, following a March 2025 inspection that revealed serious CGMP violations, misbranding, and adulteration of APIs including GLP-1 peptides and other compounding-related APIs. The firm distributed APIs ineligible for 503A compounding (including retatrutide, cagrilintide acetate, and multiple peptides), received shipments mislabeled as 'custom peptide' to obscure drug identity, sourced from unregistered or non-compliant foreign manufacturers, and failed to maintain adequate quality unit oversight, supplier qualification, complaint investigation, and pre-release testing. FDA characterized the APIs as adulterated and misbranded under multiple FD&C Act provisions and required a written response within 15 working days along with extensive corrective actions.

Xcel Research LLC

FDA issued a warning letter to Xcel Research LLC (xcelpeptides.com) in December 2024 for selling unapproved new drugs — including Retatrutide, Cagrilintide/Semaglutide blends, Mazdutide, Semaglutide, Survodutide, and Sermorelin — marketed under the guise of 'research use only' products. The website's own claims established intended human use by describing therapeutic effects such as weight loss, blood sugar regulation, cardiovascular protection, and neuroprotection. The products violate FD&C Act sections 505(a) and 301(d) as unapproved new drugs lacking any FDA-approved application. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Warrior Labz SARMS

FDA issued a warning letter to Warrior Labz SARMS (Jeremy Brown, Simi Valley/Agoura Hills, CA) in June 2023 after reviewing the company's website and Instagram, finding that products including SARMs (RAD-140, MK-677, MK-2866, LGD-4033), peptides (BPC-157, TB-500), prohormones (19-Nor Andro, 4-Andro), and unapproved sildenafil/tadalafil formulations were being marketed with drug claims for human use despite 'research only' disclaimers. FDA determined these products are unapproved new drugs sold in violation of FD&C Act sections 505(a) and 301(d). The agency cited safety concerns including liver toxicity, increased heart attack and stroke risk, and dangers of injectable/intranasal administration. Warrior Labz was required to respond within 15 working days with corrective steps, and failure to comply could result in seizure and injunction.

Innoveix Pharmaceuticals Inc

FDA issued a warning letter to Innoveix Pharmaceuticals Inc. (Addison, TX) following a May 2021 inspection that found serious sterility and insanitary-conditions violations in the compounding of injectable peptide products, including Sermorelin/Ipamorelin and AOD-9604. The firm had already voluntarily recalled both products due to lack of sterility assurance. FDA cited multiple CGMP failures — including use of an unsuitable sterilization unit, improper aseptic technique, and use of household dish detergent on sterile glassware — constituting adulteration under FDCA section 501(a)(2)(A). The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine

Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine, operated by Dr. Leonard D. Guyer in Indianapolis, IN, received an FDA Warning Letter following a 2020 inspection that found the facility producing compounded sterile drug products under insanitary conditions and without meeting the conditions of section 503A of the FDCA. The facility used bulk drug substances including peptides such as BPC-157, thymosin alpha, thymosin beta, LL-37, Selank, and Semax that are ineligible for 503A exemptions, and produced drugs without valid patient-specific prescriptions. The violations encompass adulterated and misbranded drug products, unapproved new drug marketing, and serious CGMP deficiencies including unclassified sterile processing areas, lack of environmental monitoring, and improper aseptic technique. The firm was required to respond within 15 working days and must notify FDA 15 working days before resuming sterile production; failure to correct violations may result in seizure or injunction.