FDA 483 - Advanced Pharmaceutical Technology Inc. - August 01, 2024

Advanced Pharmaceutical Technology Inc. in Elmsford, NY, a drug manufacturer, was cited for numerous significant deficiencies during an FDA inspection. The firm failed to ensure proper testing and release of drug products, lacked adequate quality control oversight for contract manufacturers and laboratories, and exhibited major issues with process validation, sterilization validation, and stability testing for its subcutaneous pellet products. Additionally, the inspection revealed deficient batch records, unmonitored drug storage conditions, and the use of unqualified API suppliers, indicating a broad breakdown in GMP compliance.