FDA 483 - Aero Healthcare - May 06, 2022

An FDA inspection of Aero Healthcare in Valley Cottage, NY, a monograph drug facility, revealed significant deficiencies in its quality control unit, facility security, and employee training. The firm failed to establish written quality agreements for OTC drug products manufactured by contract manufacturers and did not adequately review Certificates of Analysis. Additionally, access to labeling materials was not restricted, and GMP training for employees was insufficient.