B. Braun Medical IncNovember 21, 2025

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

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Record Details

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.

Company: B. Braun Medical Inc
Inspection Date: November 21, 2025
Product Type: Drugs
Office: Los Angeles District Office
People: Walden H. Lee (Chemist/Investigator - Pharmaceutical Quality)
Andrew Le (Regulatory Affairs Specialist)
Roger F. Zabinski (Investigator)
Lillian S. Wu
Joey V. Quitania (Public Affairs Specialist)

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