FDA EIR - Berkeley Biologics LLC - June 25, 2021

An FDA inspection of Aziyo Biologics Inc. in Richmond, CA, was conducted from June 17-25, 2021, under the regulatory framework for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (CP7341.002). This for-cause inspection was prompted by severe adverse events, including multiple post-surgical infections and three patient deaths, linked to the firm's FiberCel Fiber Viable Matrix, Lot # NMDS210011, with several patients testing positive for Tuberculosis. Key issues revealed that the firm's sterility testing method for Fiber Viable Bone Matrix was inadequate and would not have detected the agent causing Tuberculosis, as it required different media. Furthermore, unprocessed skin from the donor implicated in the adverse events was not properly quarantined during the inspection. In response, Aziyo Biologics initiated a voluntary recall of the affected FiberCel lot, halted the production of Fiber Viable Bone Matrix, and began a market withdrawal for certain TranZgraft Achilles Tendon lots. Corrective actions included recalling all unused human tissue from the implicated donor. Preventative actions, such as revising donor acceptability criteria, are being considered pending the company's ongoing root cause investigation. No FDA Form 483 was issued at the conclusion of this inspection.