FDA EIR - Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. - August 28, 2018

A routine FDA inspection of Aziyo Biologics Inc. in Richmond, CA, was conducted from August 20-28, 2018. This inspection, part of the Office of Biological Product Operations' 2018 work plan, focused on human cells, tissues, and cellular and tissue-based products (HCT/Ps) in accordance with Compliance Program 7341.002. The inspection covered significant changes since the previous review, including the introduction of five new products like OsteGro, ViBone®, and the Altiply® amniotic membrane product lines. The scope also included a review of donor eligibility, manufacturing processes, labeling, and a new electronic system for managing tissue information. Notably, this electronic system was identified as not being Part 11 compliant, but the company clarified it was not used for official record-keeping, a statement verified during the inspection. Crucially, the inspection concluded without the issuance of an FDA Form 483 Inspectional Observations, indicating that no significant regulatory violations were found. Furthermore, a previously FDA-monitored recall was reviewed and found to have adequate corrective and preventative actions, leading to its official termination. Therefore, no specific regulatory actions were required from this inspection.