Pharmaplast S.A.E. – FDA 483, Feb 6, 2025

Pharmaplast S.A.E., an OTC drug manufacturer in Alexandria, Egypt, was cited for significant deficiencies across its laboratory controls, quality unit operations, computerized systems, and record-keeping during an FDA inspection. The observations highlight a systemic lack of data integrity, inadequate testing procedures, ineffective quality oversight, and insufficient control over critical manufacturing processes and documentation. These issues indicate a serious failure to ensure the safety, efficacy, purity, and overall quality of drug products distributed to the US market.