FDA 483 - ARx LLC - June 03, 2022

ARX LLC, a contract human drug manufacturer and packager in Glen Rock, PA, was cited for significant deficiencies across its quality control, manufacturing, and data integrity systems. Observations included failures in cleaning validation, pest control investigations, equipment maintenance, computer system controls, batch record documentation, environmental controls, and process validation. These issues indicate a broad lack of adherence to current good manufacturing practices.