# FDA 483 - Axogen Corp - Unknown Date

Source: https://www.keypedia.com/records/483/axogen-corp/f6fe6848-4973-44ee-a9cd-edfd3872e044

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Axogen Corporation, a drug substance and drug product manufacturer in Vandalia, OH, was cited for significant deficiencies across its manufacturing and quality systems. Observations included inadequate environmental monitoring, insufficient contamination controls, deficient production procedures, and poor laboratory and deviation management, indicating a lack of robust controls to ensure product quality and purity.

## Related Officers

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd