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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.