FDA 483 - Advanced Pharmaceutical Technology Inc. - August 23, 2021

Advanced Pharmaceutical Technology Inc. in Elmsford, NY, was inspected by the FDA from August 5-23, 2021, and received a Form 483 with seven observations. The inspection revealed significant deficiencies in quality control, manufacturing process validation, stability testing, equipment cleaning procedures, supplier qualification, and employee training for their Testosterone and Estradiol Subcutaneous Pellet drug products. These issues indicate a lack of adherence to cGMP requirements, posing potential risks to product quality and patient safety.