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

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.