US Specialty Formulations LLC – FDA 483, Apr 26, 2022

During an inspection conducted from March 21 to April 26, 2022, the U.S. Food and Drug Administration (FDA) issued a Form 483 to US Specialty Formulations LLC, an outsourcing facility in Allentown, PA. The inspection revealed numerous significant violations related to Current Good Manufacturing Practices (cGMP), particularly concerning the production of sterile drug products. Key observations highlighted critical deficiencies in aseptic processing, environmental control, and quality assurance. Specifically, the FDA noted inadequate air handling systems with obstructed airflow and uncertified ISO 5 areas under dynamic conditions. Procedures to prevent microbiological contamination were not followed, including improper handling of sterile components and insufficient gowning practices. The facility's cleaning and disinfection methods were found lacking, with repeat citations for inadequate contact times and use of non-sterile wipes in critical areas. Further issues included an unscientific environmental monitoring program, unvalidated sterilization processes, and a lack of proper calibration for critical equipment. The firm failed to conduct crucial product testing, such as container closure integrity and sterility for terminally sterilized products, and lacked robust stability data to support product expiration dates. Investigations into quality deviations, including microbial contamination and foreign matter in products, were incomplete or released batches before resolution. Additionally, product labels were deficient, and a bulk drug substance was manufactured by an unregistered facility, violating regulatory requirements. The company is required to implement comprehensive corrective actions to address these systemic failures and ensure the safety and quality of its drug products.