FDA EIR - Elutia Inc - December 30, 2019

A FDA inspection of Aziyo Biologics' Roswell, GA facility was conducted from December 11 to December 30, 2019. This Level I QSIT inspection, performed under Compliance Program 7382.845 for Medical Device Manufacturers, focused on the company’s Class II medical devices, particularly the CanGaroo ECM Envelope surgical mesh. The inspection revealed two significant issues documented on an FDA Form 483. Firstly, the results of the design risk analysis were not adequately documented (21 CFR 820.30(g)). Specifically, the firm failed to properly implement a reduced 30-month shelf-life for the CanGaroo ECM Envelope and did not notify customers who purchased devices with the original 36-month label between April and December 2019, without adequately assessing the adverse impact of this oversight. Secondly, corrective and preventive action (CAPA) activities and their results were not adequately documented (21 CFR 820.100(b)). A specific Corrective Action Request (CAR No. 6013) related to suture breakage was not properly investigated, documented, or managed according to the company’s internal procedures. In response, Aziyo Biologics’ management acknowledged the observations and promised corrections. They were advised to provide a formal response within 15 business days for consideration in the agency's regulatory compliance evaluation and are responsible for correcting all identified quality system violations.