Stem Cell / Regenerative

Blue Horizon International, LLC

FDA's Center for Biologics Evaluation and Research issued a warning letter to Blue Horizon International, LLC (Dr. Brian Mehling, CMO/Founder) in Hackensack, NJ, citing the company's marketing of unapproved umbilical cord blood-derived Stem Cell Therapy and WJ-MSC-derived Exosome Therapy for allogeneic use without a valid biologics license application (BLA) or investigational new drug (IND) application. The company's website made extensive disease-treatment claims spanning neurological, cardiovascular, musculoskeletal, metabolic, and other conditions, rendering the products unapproved new drugs and unlicensed biological products under the FD&C Act and PHS Act. Both products were also found to be misbranded under section 502(f)(1) for failing to bear adequate directions for use. FDA warned that failure to respond adequately may result in seizure and/or injunction.

BioXtek LLC

FDA issued a warning letter to BioXtek LLC (CEO Bruce R. Werber, DPM) in Pompano Beach, FL, after a February 2025 facility inspection found that its human amniotic membrane-derived products, Sanoplast ECM and Sanoplast Duo, are being marketed and distributed as unapproved new drugs and unlicensed biological products in violation of the FD&C Act and PHS Act. The products' website claims—including accelerating wound healing, tendon repair, nerve regrowth, and anti-fibrotic/anti-inflammatory effects—establish drug/biologic intent without an approved BLA. FDA warned that failure to address these violations may result in seizure and/or injunction, and required a written response within 15 working days.

Lux Therapeutics LLC dba Ponya Therapeutics LLC

FDA issued a warning letter to Lux Therapeutics LLC dba Ponya Therapeutics LLC (Brookhaven, GA) following a June 2025 inspection that found significant violations of 21 CFR Part 1271 governing human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to validate its manufacturing process for its dehydrated dual-layer amniotic membrane patch (TheraMend) and failed to include required communicable disease test summaries with distributed products. FDA found the firm's corrective responses inadequate, particularly its plan to continue distributing TheraMend without a validated process, and demanded a written response within 15 working days outlining corrective actions or face further regulatory action.

New Life Medical Services, LLC

FDA issued a warning letter to New Life Medical Services, LLC (Lutz, FL) following a May 2024 facility inspection, finding that its umbilical cord-derived products (Restor+, Regain, Renyte), amniotic fluid-derived product (ReCyte/Cytosomes), and exosome product (Rexo) are unapproved new drugs and unlicensed biological products marketed for treating pain, inflammation, neuropathy, orthopedic conditions, and tissue regeneration without an approved BLA. The products also fail HCT/P regulatory criteria under 21 CFR 1271.10(a) because they are more than minimally manipulated and are not intended for homologous use only. FDA warned that failure to address these violations may result in seizure and/or injunction, and required a written response within 15 working days.

Cellebration LLC

FDA issued a warning letter to Cellebration LLC (San Juan, Puerto Rico) after the company failed to provide records requested under section 704(a)(4) of the FD&C Act regarding its cord blood-derived cellular products marketed for treating conditions including autism, cerebral palsy, multiple sclerosis, and Parkinson's disease. The company repeatedly delayed and ultimately never submitted the requested records despite multiple extensions and follow-up communications spanning October 2024 through May 2025. FDA determined the products constitute unapproved drugs and biological products under the FD&C Act and PHS Act, and that the refusal to provide records violates section 301(e) of the FD&C Act. FDA warned that failure to adequately address the matter may result in seizure and/or injunction without further notice.

NuVida Medical LLC

FDA issued a warning letter to NuVida Medical LLC (Phoenix, AZ) after a February 2025 inspection found the company distributing four unapproved biological products — Procenta, XCELLERATE, completeFT, and Coll-e-Derm — derived from human amniotic, placental, and dermal tissue without an approved Biologics License Application (BLA). The products were marketed for wound care and revascularization applications that FDA determined constitute non-homologous use under 21 CFR 1271.10(a)(2), disqualifying them from the HCT/P exemption and making them unlicensed biological products and unapproved new drugs. FDA found NuVida's voluntary website corrections insufficient because the products' intended non-homologous uses remained unchanged. Failure to adequately respond may result in seizure and/or injunction.

Platinum Biologics LLC

FDA's Center for Biologics Evaluation and Research issued a warning letter to Platinum Biologics LLC (Orlando, FL) on August 15, 2025, citing four products — Nano PRP Jelly, Nano Flex, NanoEx, and Nano Xsomes — as unapproved new drugs and unlicensed biological products under the FD&C Act and PHS Act. The products, derived from umbilical cord tissue and exosomes, were marketed for allogeneic use to treat conditions including autoimmune disease, pain, depression, connective tissue repair, shoulder injuries, and heart failure without an approved Biologics License Application. FDA warned that failure to address violations may result in seizure and/or injunction, and required a written response within 15 working days.

Innate Healthcare Institute

FDA's Center for Biologics Evaluation and Research issued a warning letter to Innate Healthcare Institute (Scottsdale, AZ) and its founder Travis Whitney, NMD, for marketing unapproved umbilical cord mesenchymal stem cells (UC-MSCs) and exosomes as treatments for autism, osteoarthritis, COPD, heart disease, and numerous other conditions without a valid Biologics License Application (BLA). The agency found the UC-MSC product fails the minimal manipulation and homologous-use criteria under 21 CFR 1271.10(a), making it an unapproved biological drug subject to premarket review. The product was also deemed misbranded under FD&C Act section 502(f)(1) for lacking adequate directions for use. FDA warned that failure to respond adequately may result in seizure and/or injunction.

Supreme Rejuvenation, LLC

FDA's Center for Biologics Evaluation and Research issued a warning letter to Supreme Rejuvenation, LLC (Houston, TX) in May 2025 for marketing human umbilical cord mesenchymal stem cell-derived exosome products without an approved biologics license application or investigational new drug application. The company's website and Instagram page made numerous disease-treatment and structure/function claims for conditions including traumatic brain injury, arthritis, fibromyalgia, COVID-19 long-haulers, dementia, and androgenetic alopecia. FDA characterized the products as unapproved new drugs under FD&C Act § 505(a) and unlicensed biological products under PHS Act § 351(a)(1), warning that failure to respond adequately may result in seizure and/or injunction.

Chara Biologics, Inc.

FDA issued a warning letter to Chara Biologics, Inc. (CEO Joy Kong, M.D.) following a July–August 2024 facility inspection, finding that its three products—CharaExo (amniotic fluid), CharaCore, and CharaOmni (umbilical cord-derived)—are unapproved new drugs and unlicensed biological products marketed for a wide range of serious diseases including Parkinson's, ALS, autism, and diabetes without an approved BLA or active IND. The products were also found to violate CGMP and CGTP requirements, and CharaExo was misbranded due to unsupported expiration date extensions. FDA warned that failure to adequately respond may result in seizure and/or injunction.

BioStem Life Sciences

FDA issued a warning letter to BioStem Life Sciences (Pompano Beach, FL) on January 17, 2025, citing that its umbilical cord-derived and amniotic membrane products (OROPRO®, PROVISCUS®, NEOFYL®, and RHEO®) are unapproved biological drugs lacking a valid Biologics License Application (BLA), and that the products fail HCT/P criteria for minimal manipulation and homologous use. The letter also documents five significant CGMP violations covering environmental monitoring, cleaning validation, process validation, laboratory controls, and stability testing. FDA warned that failure to adequately respond may result in seizure and/or injunction.

Evolutionary Biologics Inc.

FDA's Center for Biologics Evaluation and Research issued a warning letter to Evolutionary Biologics Inc. (CEO Jim Morrison) on December 30, 2024, finding that three products — EXO RNA™ (exosome), EVO JEL™ (umbilical cord-derived), and EVO HYBRID™ (umbilical cord/placental/amniotic membrane) — are unapproved new drugs and unlicensed biological products marketed with disease-treatment and structure/function claims. The products lack approved BLAs or NDA approvals and fail HCT/P minimal-manipulation and homologous-use criteria under 21 CFR 1271.10(a). FDA also flagged three additional products (EXO RX™, EXO ELIXIR™, EXO PERIO™) for similar concerns and warned that failure to respond adequately may result in seizure and/or injunction.

Skye Biologics Holdings LLC

FDA issued a warning letter to Skye Biologics Holdings LLC (El Segundo, CA) following a November–December 2022 inspection, finding that its umbilical cord-derived 'placental connective tissue matrix allograft' products (BioECM™ line) are unapproved new drugs and unlicensed biological products marketed without a valid Biologics License Application (BLA). The products were found to exceed minimal manipulation thresholds and were not intended for homologous use, disqualifying them from regulation solely under PHS Act section 361. FDA also documented seven categories of significant CGMP violations, including lack of process validation, inadequate environmental monitoring, missing endotoxin testing, and unsupported five-year expiration dating. FDA warned that failure to adequately respond may result in seizure and/or injunction.

XO Biologix, LLC

FDA issued a warning letter to XO Biologix, LLC (Austin, TX) on December 12, 2024, regarding its amniotic fluid-derived product MaviX™. The agency found MaviX™ to be an unapproved new drug and unlicensed biological product under the FD&C Act and PHS Act, marketed with claims that it reduces pain, inflammation, and regenerates tissue without an approved Biologics License Application. The product was also found adulterated due to CGMP violations at its manufacturer and misbranded due to false or misleading labeling, including inconsistent and unsupported shelf-life claims. FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure and/or injunction.

INCELL Corporation LLC

FDA's Center for Biologics Evaluation and Research issued a Warning Letter to INCELL Corporation LLC (San Antonio, TX) on December 12, 2024, finding that its amniotic fluid-derived product is an unapproved new drug and unlicensed biological product under the FD&C Act and PHS Act. The company also committed multiple CGMP violations including failure to validate aseptic processes, lack of identity testing specifications, and unsupported expiration dating. The product's Instructions for Use were found to contain false or misleading labeling, rendering it misbranded, and FDA warned that failure to remediate may result in seizure and/or injunction.

Frontier Biologics, LLC

FDA issued a warning letter to Frontier Biologics, LLC (Waco, TX) after a February–March 2024 inspection found that its human amniotic fluid and amniotic membrane allograft products are being marketed and distributed as unapproved new drugs and unlicensed biological products in violation of the FD&C Act and PHS Act. The company's marketing materials made therapeutic claims for wound healing, inflammation reduction, and orthopedic use without an approved BLA or active IND. FDA also cited six significant CGMP violations including failure to validate aseptic processes, inadequate environmental monitoring, and two uninvestigated sterility failures. The letter warns that failure to adequately respond may result in seizure and/or injunction.

Amnio Technology, LLC

FDA issued a warning letter to Amnio Technology, LLC (Phoenix, AZ) regarding its amniotic membrane and amniotic fluid-derived products, PalinGen® Flow® and PalinGen® InovōFlo®, finding them to be unapproved new drugs and biological products marketed without a valid Biologics License Application (BLA) or approved NDA. The company's promotional materials made wound healing, tissue regeneration, anti-inflammatory, and anti-microbial claims that triggered drug/biologic classification under the FD&C Act and PHS Act. FDA also documented significant CGMP deviations including lack of process validation, inadequate stability testing, and failure to report adverse events. The letter warns that failure to adequately respond may result in seizure and/or injunction.

Pinnacle Transplant Technologies, LLC

FDA issued a warning letter to Pinnacle Transplant Technologies, LLC (Phoenix, AZ) regarding its amniotic membrane and amniotic fluid-derived products, PalinGen®, which FDA determined are unapproved new drugs and biological products lacking required BLA or IND authorization. Promotional materials claimed the products support wound healing and tissue regeneration, triggering classification as drugs under the FD&C Act and biological products under the PHS Act. FDA also documented six significant CGMP deviations including failures in aseptic process validation, sterility failure investigations, and environmental monitoring. The letter warns that failure to adequately respond may result in seizure and/or injunction.

Mother Stem Institute, Corp.

FDA's Center for Biologics Evaluation and Research issued a warning letter to Mother Stem Institute, Corp. (Coral Gables, FL), founded by Dr. Alvaro Skupin, after reviewing the firm's website and records related to its stromal vascular fraction (SVF) product derived from enzymatic digestion of adipose tissue. The firm's website marketed the SVF product for treatment of Alzheimer's disease, Type I/II Diabetes, Lupus, Rheumatoid Arthritis, Parkinson's, and other conditions, establishing drug and biological product intended uses without an approved Biologics License Application or active IND. FDA found the SVF product constitutes more than minimal manipulation of a structural tissue, does not qualify for the same-surgical-procedure exception, and is both an unapproved biological drug and a misbranded drug, warning that failure to correct violations may result in seizure and/or injunction.

Regenerative Processing Plant, LLC

FDA issued a Warning Letter to Regenerative Processing Plant, LLC (owner Dr. Carl R. Harrell) in Palm Harbor, FL, citing multiple serious violations related to their Regener-Eyes® PRO and Regener-Eyes® LITE ophthalmic solutions. The products were found to be unapproved new drugs, misbranded, and adulterated due to significant CGMP failures including inadequate aseptic process validation, insufficient environmental monitoring, and unsupported stability claims. FDA also raised serious concerns that products marketed after June 2021 may still contain amniotic fluid — a biologic requiring a valid BLA — despite the company's claims of discontinuation. Failure to adequately address these violations may result in seizure and/or injunction.

Neobiosis, LLC

FDA issued a warning letter to Neobiosis, LLC (Gainesville, FL), a manufacturer of amniotic fluid and umbilical cord-derived products, following a January–February 2023 inspection. The agency found that Neobiosis's products (Purified Amniotic Fluid, Wharton's Jelly Cellular, and Wharton's Jelly Acellular) are unapproved drugs and biological products marketed for wound healing and orthopedic uses without approved Biologics License Applications or active INDs, in violation of the FD&C Act and PHS Act. The firm also had significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, and unsupported expiration dating. FDA warned that failure to adequately address these violations may result in seizure and/or injunction.

Akan Biosciences, Inc.

FDA issued a warning letter to Akan Biosciences, Inc. (Gaithersburg, MD) following a September 2022 inspection of their manufacture and distribution of Ayama™, an allogeneic adipose-derived stromal vascular fraction (SVF) cellular product. The product was found to be an unapproved biological drug lacking a valid biologics license application or IND, and failed to meet HCT/P minimal manipulation and homologous use criteria under 21 CFR 1271. FDA documented multiple serious violations including inadequate donor communicable disease screening and testing, distribution of quarantine-status product, and failure to validate manufacturing processes, affecting 585 vials from three donors. FDA warned that failure to adequately address these violations may result in seizure and/or injunction.

Signature Biologics, LLC

FDA issued a warning letter to Signature Biologics, LLC (Irving, TX) regarding its Signature Cord™ product, derived from human umbilical cord tissue and distributed to healthcare professionals for allogeneic injection use. The agency found the product constitutes an unapproved biological drug requiring a valid Biologics License Application (BLA) or active IND, neither of which was in place, and that it fails the minimal manipulation and homologous use criteria under 21 CFR 1271.10(a). FDA also documented seven significant CGMP deviations including inadequate aseptic process validation, insufficient environmental monitoring, missing endotoxin testing, unvalidated manufacturing processes, and unsupported expiration dating. Failure to adequately respond may result in seizure and/or injunction.

Kimera Labs, Inc.

FDA issued a Warning Letter to Kimera Labs, Inc. (Miramar, FL) regarding its exosome products XoGlo®, XoGlo®Pro, and amniotic fluid product Amnio2X®, which were manufactured and distributed without an approved Biologics License Application (BLA) or valid IND, constituting unapproved biological drug products under the FD&C Act and PHS Act. The inspection uncovered at least 10 significant CGMP violations affecting over 37,000 vials, including failures in aseptic process validation, sterility testing, environmental monitoring, and laboratory controls. FDA noted that Kimera continued distributing products after a prior 2020 Untitled Letter put them on notice, and that serious adverse events had been reported in patients treated with exosome products. FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure and/or injunction.

Row1 Inc. dba Regenative Labs

FDA issued a warning letter to Row1 Inc. dba Regenative Labs (Pensacola, FL) regarding its umbilical cord-derived cellular products (ProText™, CoreText™, CryoText™ Pro, CryoText™ Plus, SecreText™, and SecreText™ Pro), finding they constitute unapproved biological drugs requiring a Biologics License Application (BLA) or active IND, neither of which the company holds. The products failed to meet the homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a), meaning they cannot be regulated solely as HCT/Ps under section 361 of the PHS Act. FDA also documented significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, improper personnel practices, and unsupported five-year expiration dating. The letter warns that failure to adequately respond may result in seizure and/or injunction.

Stratus Biosystems, LLC dba CellGenuity Regenerative Science

FDA issued a warning letter to Stratus Biosystems, LLC dba CellGenuity Regenerative Science for manufacturing and distributing unapproved biological products — AmnioAMP-WJ™ (umbilical cord/amniotic membrane-derived) and AmnioAllograft (amniotic fluid-derived) — without a valid Biologics License Application (BLA) or Investigational New Drug (IND) application in effect. The products were marketed for broad non-homologous uses including orthopedics, neurology, cardiac, and oncology applications, disqualifying them from the 21 CFR 1271 section 361 exemption. FDA also documented extensive CGMP violations including unvalidated aseptic processes, inadequate environmental monitoring, sterility and endotoxin failures without investigation, and expiration dates assigned without stability testing. The letter demands a written response within 15 working days and warns that failure to comply may result in seizure and/or injunction.

RenatiLabs Inc.

FDA issued a warning letter to RenatiLabs Inc. (Erlanger, KY) following an August 2022 inspection of their manufacture and distribution of WJMAX™, a Wharton's jelly/umbilical cord-derived product intended for allogeneic intra-articular injection and wound treatment. FDA determined WJMAX™ is an unapproved biological drug product lacking a valid biologics license application (BLA) or investigational new drug (IND) application, and that it fails the homologous use and minimal manipulation criteria under 21 CFR 1271.10(a). The agency also documented serious CGMP violations including release of a lot that failed sterility testing due to Staphylococcus epidermidis contamination, lack of aseptic process validation, and unsupported four-year expiration dating. FDA warned that failure to adequately respond may result in seizure and/or injunction.

Invitrx Therapeutics, Inc.

FDA issued a Warning Letter to Invitrx Therapeutics, Inc. (Lake Forest, CA) following a March 2022 inspection documenting that the company manufactured and distributed unapproved biological products — including a human umbilical cord-derived mesenchymal stem cell product (Invitra UC-MSC™) and exosome products (Invitra EX™ and Invitra EV-OP™) — without an approved Biologics License Application or an active IND, in violation of the FD&C Act and PHS Act. The letter also cited extensive CGMP and CGTP deviations including unvalidated aseptic processes, deficient donor eligibility determinations, inadequate sterility testing, and failure to investigate adverse event complaints. This was a repeat action following a March 2020 Warning Letter for the same firm, and FDA warned that failure to adequately respond could result in seizure and/or injunction.

Vitti Labs, LLC

FDA issued a warning letter to Vitti Labs, LLC, a Liberty, MO manufacturer of human umbilical cord- and amniotic membrane-derived products (EV-PURE+, WJ-PURE+, VITTI-PURE, NS-PURE, EV-OPTI DROPS), finding that these HCT/Ps are unapproved biological drug products marketed without a valid biologics license application (BLA) or investigational new drug (IND) application. The products failed to meet the homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a), and the inspection documented significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, and unsupported two-year expiration dating. FDA warned that failure to adequately respond may result in seizure and/or injunction.

Re-Gen Active Lab, Inc.

FDA issued a warning letter to Re-Gen Active Lab, Inc. (Irving, TX) regarding three amniotic membrane and umbilical cord tissue-derived cellular products — ActiveFlow™, ActiveShot™, and ActivePro™ — distributed to physicians and medical clinics nationwide. The products were found to be unapproved biological drugs lacking a valid Biologics License Application (BLA) or Investigational New Drug (IND) application, and failed to meet HCT/P homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a). FDA also documented nine significant CGMP deviations including failure to validate aseptic processes, inadequate sterility testing, and unsupported two-year expiration dating. The letter warns that failure to adequately respond may result in seizure and/or injunction.

Smart Surgical, Inc dba Burst Biologics

FDA issued a warning letter to Smart Surgical, Inc. dba Burst Biologics (Boise, ID) regarding its BioBurst Fluid and BioBurst Rejuv products derived from human umbilical cord blood, which FDA determined are unapproved biological drugs lacking a valid biologics license application (BLA) or investigational new drug (IND) application. The company's website marketing indicated the products were intended to treat various diseases and conditions, and the products failed to meet the homologous-use and other criteria required for regulation solely under section 361 of the PHS Act. FDA also documented serious CGMP/CGTP deviations including deficient donor screening (Zika virus risk), unvalidated aseptic processes, inadequate environmental monitoring, and numerous uninvestigated sterility failures. FDA warned that failure to address these violations may result in seizure and/or injunction.

Surgenex LLC

FDA issued a warning letter to Surgenex LLC (Scottsdale, AZ) regarding its manufacture and distribution of three allogeneic HCT/P products — SurCord®, SurForce®, and SurFactor® — derived from umbilical cord and amniotic membrane and marketed for orthopedic conditions. The products were found to be unapproved biological drugs lacking a valid biologics license application or IND, and failed to meet homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a). FDA also documented significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, uninvestigated sterility failures, and unsupported expiration dating, raising potential significant patient safety concerns. FDA demanded a written response within 15 working days and warned that failure to correct violations may result in seizure and/or injunction.

Utah Cord Bank LLC dba Utah Cell Bank

FDA issued a Warning Letter to Utah Cord Bank LLC dba Utah Cell Bank (owner Eliott D. Spencer, PhD) following a February 2021 inspection of its Sandy, Utah facility, finding that its allogeneic cellular products—StemVive®, StemMaxx™, StemTru™, and StemCellect™—derived from umbilical cord blood, cord tissue, and amniotic membrane, are unapproved biological drugs marketed without a valid Biologics License Application (BLA) or Investigational New Drug (IND) application. The products failed to meet the homologous-use and minimal-manipulation criteria required for regulation solely under section 361 of the PHS Act, and the inspection documented 14 significant CGMP/CGTP deviations including unvalidated aseptic processes, 16 uninvestigated sterility failures, and inadequate batch records. FDA warned that failure to adequately address these violations may result in seizure and/or injunction, and required a written response within 15 working days.

Utah Cord Bank LLC

FDA issued a warning letter to Utah Cord Bank LLC (Sandy, UT) following a February 2021 inspection that identified significant deviations from 21 CFR Part 1271 regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps), specifically cord blood banking operations. The violations included failure to validate manufacturing processes, inadequate environmental monitoring, absence of required standard operating procedures across multiple operational areas, and incomplete recordkeeping. No marketing claims were flagged; the enforcement concerns centered entirely on manufacturing and quality-system deficiencies. FDA required a written corrective action response within 15 working days and warned that failure to correct violations could result in regulatory action without further notice.

Regenerative Medical Group, Inc.

Regenerative Medical Group, Inc. was the subject of an FTC enforcement action alleging that the company deceptively advertised 'amniotic stem cell therapy' to consumers between 2014 and 2017. The FTC found the marketing claims to be deceptive and ordered consumer redress. As a result, the FTC mailed 270 checks totaling nearly $515,000 to harmed consumers, with an average payment of approximately $1,907 per consumer.