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

An FDA inspection of B. Braun Medical Inc. in Daytona Beach, FL, identified significant issues in their sterile drug manufacturing processes. Deficiencies included inaccurate yield calculations in batch records, inadequate contamination control procedures, and improper storage of raw materials. The firm also failed to properly characterize and document reasons for rejected in-process materials, indicating a need for improved quality control and adherence to cGMP regulations.