# FDA 483 - B. Braun Medical Inc - November 21, 2025

Source: https://www.keypedia.com/records/483/b-braun-medical-inc/4ef2fe5d-e907-456f-b54e-e3da8ce6e855

> FDA 483 for B. Braun Medical Inc on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B. Braun Medical Inc
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: B. Braun US Pharmaceutical Manufacturing, LLC in Irvine received a Form 483 citing significant deficiencies across multiple areas. The firm failed to ensure the quality of its IV bag products due to inadequate visual inspection for particulate matter, insufficient investigations into product defects, and prolonged open nonconformances. Additionally, issues were noted with water system maintenance, sterility test investigations, and supplier re-qualification.

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## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)
- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)
- [Public Affairs Specialist](https://www.keypedia.com/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)

Company: https://www.keypedia.com/companies/b-braun-medical-inc/7d193a37-e8a0-4f0f-aeea-f64ccd959191

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b