FDA 483 - B. Braun Medical Inc - July 23, 2020

An FDA inspection of B. Braun Medical Inc. in Irvine, CA, a sterile drug manufacturer, revealed significant deficiencies in its quality control unit. The firm has multiple long-standing corrective and preventive actions (CAPAs) that remain incomplete, some dating back to a 2017 Warning Letter and a 2018 FDA-483. Additionally, investigations into out-of-specification (OOS) sterility test results were found to be inadequate, lacking proper follow-up and retraining, and critical equipment surfaces were observed to be worn, potentially compromising drug product quality.