FDA 483 - AMMAN PHARMACEUTICAL INDUSTRIES

An FDA inspection of Amman Pharmaceutical Industries, a sterile drug manufacturer, revealed severe deficiencies in aseptic processing, environmental monitoring, and laboratory controls. Observations included poor aseptic techniques, inadequate validation of sterile processes, falsified or incomplete laboratory records, and a failure to thoroughly investigate discrepancies. The findings indicate a critical lack of control over sterile drug manufacturing and data integrity.