FDA 483 - B. Braun Medical Inc. - October 30, 2020

B. Braun Medical Inc. in Daytona Beach, FL, a sterile drug manufacturer, received a Form 483 with nine observations during an inspection from October 19-30, 2020. The observations highlight significant deficiencies across its quality control, production, computer systems, environmental controls, material testing, and laboratory practices. Key issues include inadequate process validation, poor data integrity controls, and a failure to follow established SOPs for manufacturing and quality oversight.