FDA 483 - Advanced Pharmaceutical Technology Inc. - September 27, 2019

Advanced Pharmaceutical Technology LLC, a drug product manufacturer in Elmsford, NY, was inspected and cited for significant deficiencies in its manufacturing processes. The firm failed to conduct essential testing for drug product release, lacked process and cleaning validations, and had no adequate stability or supplier qualification programs. These issues indicate a severe lack of control over the quality and purity of its Testosterone and Estrogen Subcutaneous Pellet drug products.