FDA 483 - Medline Industries, Inc. - August 10, 2022

During an inspection conducted from July 11 to August 10, 2022, the FDA observed significant deviations from Current Good Manufacturing Practices (cGMP) at B. Braun Medical Inc.'s drug manufacturing facility in Allentown, PA. The inspection report, known as an FDA Form 483, highlighted six key issues, several of which were repeat observations from previous inspections.

Primary violations included failures in aseptic processing, specifically regarding adherence to proper aseptic techniques by personnel during media fills, which raises concerns about potential microbiological contamination of sterile drug products. The company's sterilization process validation was deemed inadequate as smoke studies did not dynamically simulate routine manufacturing operations. Furthermore, the environmental monitoring system in aseptic processing areas was found deficient, lacking comprehensive viable air and surface sampling in critical intervention zones.

Other issues involved personnel gowning practices, where non-sterile attire was used in areas adjacent to cleanrooms. The firm also failed to conduct microbial limits testing on a critical raw material for parenteral nutrition products, relying instead on an unverified vendor's certificate of analysis. Finally, a stability testing method for particulate matter in opaque parenteral nutrition emulsions was found unsuitable as it was designed for clear solutions.

B. Braun Medical Inc. is required to thoroughly address these observations to ensure compliance with federal regulations governing the manufacture of sterile drug products and to prevent product contamination and quality deficiencies.