FDA 483 - Packaging Coordinators, LLC - January 12, 2023

An FDA inspection of Packaging Coordinators, LLC in Philadelphia, PA, a drug labeler and packager, revealed significant deficiencies across multiple areas. The firm failed to establish adequate production and process controls, maintain appropriate equipment design, and ensure proper quality control unit procedures. Additionally, buildings and equipment were not kept in a clean and sanitary condition, indicating a broad lack of GMP compliance.