FDA 483 - US Specialty Formulations LLC - August 29, 2017

The FDA inspection identified multiple deficiencies at the drug manufacturing facility. Personnel gowning for aseptic operations was conducted in non-classified areas without HEPA filtered air, and an employee in an ISO 5 area had exposed street clothes during Pyridoxine crimping. The cleaning procedure for aseptic areas had insufficient disinfectant contact time, lacked pre-cleaning instructions, did not specify sterile disinfectants for ISO 5 areas, and omitted recovery time after opening for cleaning; this was a repeat observation.

Equipment maintenance was deficient, with visibly rusted lower shelves on metal tables in ISO 7 and ISO 8 cleanroom areas, which contact processing materials. Drug product release testing was inadequate, as preservative content and effectiveness were not tested for Betamethasone Acetate/Sodium Phosphate sterile vials, a repeat observation for a different product.

Computer system controls were lacking: no login was required for the operating system, raw assay data files could be deleted without audit trail recording, and multiple individuals had administrator privileges. Laboratory records were deficient, lacking a second person's signature for accuracy review. Finally, container labels for outsourcing facility drug products were non-compliant, missing required information such as "This is a compounded drug," dosage form/strength, quantity/volume, inactive ingredients, and incorrect adverse event reporting information.