# FDA 483 - Tanvex BioPharma USA, Inc - Unknown Date

Source: https://www.keypedia.com/records/483/tanvex-biopharma-usa-inc/e92cc3ba-e7d5-4009-8a18-bb079c3c8e29

> FDA 483 for Tanvex BioPharma USA, Inc on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tanvex BioPharma USA, Inc
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: The FDA inspection of Tanvex BioPharma USA, Inc. in San Diego revealed significant deficiencies in their bulk drug substance and drug product manufacturing. Key issues include inadequate quality control unit oversight, particularly concerning manual integration of chromatographic data and data integrity, and widespread problems with aseptic processing controls, equipment qualification, environmental monitoring, and written procedures. These findings indicate a systemic lack of adherence to cGMP requirements, posing potential risks to product quality and sterility.

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## Related Officers

- [Daviana Ligons, Sr. Staff Fellow](https://www.keypedia.com/people/daviana-ligons-sr-staff-fellow/15f1ae6a-eaa0-4417-8d68-366c9ce36719)
- [Amanda Pyles, Chemist](https://www.keypedia.com/people/amanda-pyles-chemist/5600bf19-3351-4c1f-92d3-ffe01175c161)
- [Diane Raccasi, Microbiologist](https://www.keypedia.com/people/diane-raccasi-microbiologist/59492d65-0826-43ae-a353-e9843e8fe602)
- [Thuy Nguyen, Acting QAL](https://www.keypedia.com/people/thuy-nguyen-acting-qal/6b1dab62-f775-4399-a70f-7e55416e0557)
- [Lindsey Brown, Microbiologist](https://www.keypedia.com/people/lindsey-brown-microbiologist/70a1963f-a644-431d-b08f-0350d582e7d3)

Company: https://www.keypedia.com/companies/tanvex-biopharma-usa-inc/03dcd4a5-e896-45c2-9c1f-1c90a4f9544d

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0