# FDA 483 - Tanvex BioPharma USA, Inc - May 04, 2022

Source: https://www.keypedia.com/records/483/tanvex-biopharma-usa-inc/3e45c7cf-3849-41b2-bd3c-2082a46745c1

> FDA 483 for Tanvex BioPharma USA, Inc on May 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tanvex BioPharma USA, Inc
- Inspection Date: 2022-05-04
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Tanvex BioPharma USA, Inc. in San Diego, a drug substance manufacturer, revealed significant deficiencies across its quality system. Observations included inadequate quality unit oversight, uncontrolled quality control tests, lack of detailed written procedures, and insufficient control to prevent microbial contamination. The firm also failed to follow its own procedures for retesting, equipment status, logbook review, supplier qualification, and deviation reporting, with some issues being repeat observations.

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## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [Yun Wu](https://www.keypedia.com/people/yun-wu/ae378596-ea82-4254-b169-b592878202eb)
- [Kristen Nickens](https://www.keypedia.com/people/kristen-nickens/d68c87e1-e14c-48f7-86e9-686a3870c777)

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

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