# FDA EIR - Axogen Corporation - November 20, 2018

Source: https://www.keypedia.com/records/eir/axogen-corporation/c5fdad80-03af-45d9-9dd0-7d2517fada2b

> FDA EIR for Axogen Corporation on November 20, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Axogen Corporation
- Inspection Date: 2018-11-20
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/abby-l-mozeke-baker/32e2896f-b836-4752-862e-de98370b8cad)

Company: https://www.keypedia.com/companies/axogen-corporation/c1a3a1ba-57e3-4747-b670-8018198f0309

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9