# FDA 483 - Axogen Corp - Unknown Date

Source: https://www.keypedia.com/records/483/axogen-corp/321cdd86-72ad-4a9d-b4be-51bcfd9fc79c

> FDA 483 for Axogen Corp on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Axogen Corp
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Axogen Corporation, a manufacturer of AVANCE drug substance and drug product in Vandalia, OH, was cited for significant deficiencies across its manufacturing and quality systems. Observations included inadequate warehousing controls, a deficient environmental monitoring program, insufficient contamination prevention measures, and inadequate production and process control procedures. Additionally, the firm was cited for inadequate laboratory controls, deficient pest control investigations, and an ineffective deviation management system, indicating a broad lack of quality oversight.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/axogen-corp/f6fe6848-4973-44ee-a9cd-edfd3872e044)

## Related Officers

- [Miriam M. Ngundi](https://www.keypedia.com/people/miriam-m-ngundi/3999979f-7a00-4d34-8aed-e4426351c99f)
- [Neetu Dahiya](https://www.keypedia.com/people/neetu-dahiya/eca2915a-15a1-4f2b-a32f-99515fdde490)
- [Wen Sueto](https://www.keypedia.com/people/wen-sueto/9d480add-af54-417d-82d3-1bec59f3ce35)
- [Lead Biologist](https://www.keypedia.com/people/jin-sung-hong/c1442e69-a994-4b70-8666-8b77485f63c7)

Company: https://www.keypedia.com/companies/axogen-corp/8b9c1a0d-6561-4eab-baf7-cc2fa49dfb30

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4