FDA 483 - B. Braun Medical Inc - December 15, 2023
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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.
ID · 20548a71-1584-4d2e-af2e-edba60893864