FDA WARNING_LETTER - Akan Biosciences, Inc. - September 30, 2022

The FDA issued a Warning Letter to Akan Biosciences, Inc. following a September 20-30, 2022, inspection. The firm manufactures Ayama™, an adipose-derived, stromal vascular fraction (SVF) cellular product for allogeneic use, marketed for "repair, reconstruct and replace your skin tissue." The FDA determined Ayama™ is an unapproved drug and biological product, not solely regulated as an HCT/P, because it fails minimal manipulation and homologous use criteria (21 CFR 1271.10(a)). The product lacks an approved biologics license application (BLA) or an investigational new drug (IND) application.

Significant violations of HCT/P regulations (21 CFR 1271) and Current Good Manufacturing Practice (CGMP) requirements (21 CFR 210 and 211) were identified for 585 vials from three donors. Violations include: 1. Failure to test donor specimens for relevant communicable disease agents (e.g., anti-HBc, HIV-1, HCV, HBV NAT) (21 CFR 1271.85(a)). 2. Failure to collect donor specimens within the required timeframe (21 CFR 1271.80(b)). 3. Failure to use FDA-licensed, approved, or cleared donor screening tests (21 CFR 127