Berkeley Biologics LLC – FDA EIR, Mar 25, 2016

An FDA inspection of Aziyo Biologics, Inc., located in Richmond, CA, was conducted from March 2 to March 25, 2016. This comprehensive inspection evaluated operations related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under FDA Compliance Program 7341.002. Although no official FDA Form 483 inspectional observations were issued, six significant areas for improvement were discussed with management. These included observed employee non-compliance with surgical hand scrub procedures and an outdated standard operating procedure (SOP) for hand scrubbing. Concerns were also raised regarding inconsistent cleanroom re-entry policies, which could affect cross-contamination prevention. The inspection highlighted the need for more specific reporting in Non-Conforming Events (NCEs) to facilitate effective trend tracking, and the absence of an SOP for the new practice of scanning hard copy documents into electronic files. Additionally, issues with incomplete preventative maintenance work orders and a lack of clear verification methods within the "Expired Allograft Inventory Management" SOP were noted. Aziyo Biologics' management, represented by VP of Technical Services/Quality Erica L. Elchin, promptly acknowledged these observations and initiated corrective actions during the inspection, such as drafting revised SOPs, reviewing operational flows, and addressing documentation deficiencies.