# FDA 483 - Tanvex BioPharma USA, Inc - January 24, 2023

Source: https://www.keypedia.com/records/483/tanvex-biopharma-usa-inc/a9d30f1e-d696-45b8-b908-bd03a01a3ccb

> FDA 483 for Tanvex BioPharma USA, Inc on January 24, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tanvex BioPharma USA, Inc
- Inspection Date: 2023-01-24
- Product Type: biologics
- 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, CA, revealed significant deficiencies in cGMP procedures and records, quality oversight, and facility and equipment maintenance. Observations included inadequate labeling for storage conditions, inaccurate batch records, and failure to follow production procedures. Additionally, the firm lacked proper trending for its pest control program, failed to qualify a cGMP storage room, and exhibited poor microbial control and cleanliness in manufacturing areas.

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## Related Officers

- [Ian L. McWilliams](https://www.keypedia.com/people/ian-l-mcwilliams/386bf0ca-a66d-4526-9b07-7771795269a1)
- [Jun Liu](https://www.keypedia.com/people/jun-liu/39e5d6f3-32fd-426f-880d-3d840a9faed2)
- [Pharmaceutical investigator](https://www.keypedia.com/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [Regulatory Scientist at FDA](https://www.keypedia.com/people/yi-wang/f5355ae0-ae28-452f-829a-786b7ebc4791)

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