FDA 483 - B. Braun Medical Inc. - January 31, 2025

An FDA inspection of B. Braun Medical Inc. in Daytona Beach, FL, revealed significant deficiencies in their sterile drug manufacturing processes. Observations included incorrect yield calculations in batch records, failures in preventing microbiological contamination, and inadequate facility space for material storage. Additionally, the firm's examination and testing procedures for drug products were found to be insufficient.