American Regent, Inc. – FDA EIR, Sep 30, 2022

An FDA cGMP surveillance inspection of American Regent, Inc. in New Albany, OH, was conducted from September 22 to September 30, 2022. The inspection, performed under regulatory guidelines for drug manufacturing and sterile drug processes (CP 7356.002, CP 7356.002a), covered multiple operational systems for sterile injectable drug products. The inspection resulted in a single FDA Form 483 observation, citing that the responsibilities and procedures of the quality control unit were not fully followed, as required by 21 CFR 211.22(d). Main issues included unauthorized modifications to a visual inspection booth—specifically, the application of packaging tape to the viewing background—without proper change control documentation. Additionally, the firm failed to investigate deviations from established HEPA recertification protocols for compounding isolators that were out of service and not tested, lacking scientific justification or written documentation for this protocol deviation. Documentation errors were also identified in critical quality records, such as unaddressed corrections in a visual inspection logbook and an equipment recertification report, and a missing verification in a batch record review. Management initiated immediate corrections and personnel training regarding the visual inspection booth modification. Addressing all observed deficiencies is essential to ensure the robust functioning of the quality control unit and compliance with good manufacturing practices.