FDA EIR - Axogen Corporation - November 20, 2018

An FDA inspection of AxoGen Corporation's Burleson, TX facility was conducted from November 19-20, 2018. The inspection assessed the company's operations involving human nerve grafts and umbilical cord, falling under the regulatory framework of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) as per Compliance Program 7341.002 and Current Good Tissue Practice (CGTP) regulations.

The primary violation identified, leading to an FDA-483 issuance, was the company's inability to account for three unprocessed umbilical cord tissues. This indicated a failure to maintain a tracking system that enables HCT/Ps traceability, as required by 21 CFR 1271.290(b). Investigation records confirmed the inability to locate these missing tissues.

Additional verbal observations discussed with management included a high number of open Non-Conformance Reports (NCRs) – 87 out of 125 – exceeding the firm's 60-day resolution standard, and insufficient documentation of corrective and preventative actions in several investigations. AxoGen management acknowledged the observations and committed to addressing all issues, including submitting a formal response to the FDA within 15 working days and implementing improvements to NCR closure timelines and corrective action processes.