Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. Warning Letter Details

Summary

Berkeley Biologics manufactured and distributed viable bone matrix products (VBM, FVBM, CFM/EFM, and OVM) derived from human bone tissue for orthopedic grafting procedures, claiming them to be sterile, but failed to comply with FDA regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) under 21 CFR Part 1271. The FDA inspection conducted September 5-25, 2023 identified that the company's products did not meet the criteria for regulation solely under section 361 of the PHS Act and were instead subject to more stringent drug, device, and/or biological product regulations under the FD&C Act and PHS Act. The company had distributed these non-compliant products throughout the United States to medical facilities.