FDA 483 - B. Braun Medical, Inc. - May 16, 2025

An FDA inspection of B. Braun Medical, Inc. in Allentown, PA, a drug product repacker and relabeller, revealed significant deficiencies across multiple quality system areas. The firm's stability program and quality control testing for drug products were found to be inadequate, particularly concerning impurity evaluation and batch release. Additionally, the inspection cited failures in thoroughly investigating out-of-specification results and field alerts, a lack of appropriate controls over computer systems for production records, and non-adherence to established procedures for handling customer complaints.