Pharmaplast S.A.E.

Warning LetterOpen

Mr. Wassim Attia Vice President of Quality/Regulatory Pharmaplast S.A.E. Amria Free Zone 30 Beside Lord International Factory Building Alexandria Governorate 21599 EgyptFEI 3003767891Issued Apr 13, 2023Center for Drug Evaluation and Research | CDER

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Violations2

Issue DateApr 13, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Pharmaplast S.A.E.
Location: Mr. Wassim Attia Vice President of Quality/Regulatory Pharmaplast S.A.E. Amria Free Zone 30 Beside Lord International Factory Building Alexandria Governorate 21599 Egypt
FEI Number: 3003767891
Country: Egypt
Issue Date: April 13, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Pharmaplast S.A.E., an Egyptian pharmaceutical manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished drug products, rendering their drugs adulterated. During a November 2022 inspection, investigators identified critical violations including failure to perform adequate identity testing on incoming components (including the active pharmaceutical ingredient ethanol), failure to test for contaminants such as methanol in ethanol and diethylene glycol or ethylene glycol in glycerin, and failure to validate supplier test analyses at appropriate intervals, all contrary to 21 CFR 211.84(d). These fundamental quality control failures meant the company lacked scientific evidence that their components and finished products met required specifications for identity, purity, strength, and quality.

Pharmaplast S.A.E. FDA Warning Letter, April 13, 2023