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

The FDA inspected Pharmaplast S.A.E. in Alexandria, Egypt, from November 6-10, 2022, and issued a Warning Letter (320-23-14) on April 13, 2023, for significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to test components for identity, purity, strength, and quality (21 CFR 211.84(d)(1) and (2))**: The firm did not adequately test incoming components, including ethanol (API) for methanol content and glycerin for diethylene glycol (DEG) or ethylene glycol (EG). Their response was inadequate, lacking detailed test plans and a strategy for previously distributed products. 2. **Failure to establish and follow adequate written procedures for equipment cleaning and maintenance (21 CFR 211.67(b))**: Cleaning validation protocols did not include all product-contact equipment, specifically transfer carriage vessels, risking cross-contamination. The firm's response was insufficient, as it did not fully evaluate all products using the vessel or justify worst-case product selection for cleaning.

The FDA placed the firm on Import Alert 66-40 on April 4, 2023. The letter requires a written response within 15 working days detailing corrective actions and recurrence prevention.