FDA 483 - Pharmaplast S.A.E. - November 10, 2022

Pharmaplast S.A.E. in Alexandria, Egypt, was inspected by the FDA, revealing significant deficiencies in its OTC drug manufacturing processes. The inspection identified issues across quality control, including inadequate finished product and component testing, poor water system maintenance, and incomplete batch records. These observations indicate a lack of adherence to current Good Manufacturing Practices, posing potential risks to drug product quality and safety.