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Omega Packaging Corp, a drug manufacturer of ethanol-based over-the-counter hand sanitizer products, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The FDA inspection from October-November 2022 identified critical failures in component testing, including inadequate identity and purity testing of incoming active pharmaceutical ingredients (specifically failing to test for methanol impurities) and failure to test glycerin for diethylene glycol contamination, while improperly relying on certificates of analysis from unqualified suppliers. The company's manufacturing methods, facilities, and controls did not conform to CGMP standards under 21 CFR parts 210 and 211, rendering their drug products adulterated. The firm had not provided corrective action responses to the FDA's Form 483 observations at the time the warning letter was issued.