FDA 483 - B. Braun Medical Inc - December 15, 2023

An FDA inspection of B. Braun Medical Inc. in Irvine, CA, revealed significant deficiencies in quality control and manufacturing practices. Observations included a failure to thoroughly investigate out-of-specification results for Heparin Sodium, inadequate annual product review procedures, and non-adherence to written testing protocols for subvisible particulate matter. These issues indicate a need for improved quality system oversight and procedural compliance at the sterile drug manufacturing facility.