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.
Flagged claims (1)
repair, reconstruct and replace your skin tissue
Required actions (2)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may lead to regulatory action without further notice. Such actions include seizure and/or injunction.
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