FDA 483 - B. Braun Medical Inc. - November 22, 2022

An FDA inspection of B. Braun Medical Inc. in Daytona Beach, FL, a sterile drug manufacturer, revealed significant deficiencies across quality control, production, and laboratory operations. The firm failed to adequately investigate product discrepancies, distributed unreleased products, and exhibited poor adherence to established procedures for visual inspections, sterility testing, and laboratory data integrity. These issues indicate a lack of robust quality oversight and could impact the quality and safety of their sterile drug products.