Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. – FDA Warning Letter, Sep 25, 2023

The FDA issued a Warning Letter to Berkeley Biologics, LLC (operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc.) following an inspection from September 5-25, 2023. The inspection documented the manufacture and distribution of viable bone matrix products (VBM, FVBM, CFM/EFM, OVM) intended for orthopedic bone grafting.

The FDA determined that VBM, CFM/EFM, and OVM products are not regulated solely as HCT/Ps under 21 CFR Part 1271 because they fail to meet the minimal manipulation criterion (21 CFR 1271.10(a)(1)) and involve combination with another article beyond allowed exceptions (21 CFR 1271.10(a)(3)). Consequently, these products are regulated as unapproved new drugs and biological products, requiring an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application, neither of which is in effect. This constitutes violations of sections 301(d) and 505(a) of the FD&C Act and section 351(a)(1) of the PHS Act.

The inspection also revealed significant deviations from Current Good Tissue Practice (CGTP) for FVBM and OVM, and Current Good Manufacturing Practice (CGMP) for VBM