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Inopak, Ltd. received a warning letter for adulterated OTC drug products, specifically SaniGuard SF foam hand sanitizer, due to significant Current Good Manufacturing Practice (CGMP) violations at their Ringwood, New Jersey facility. The company failed to establish an adequate quality unit with documented responsibilities and procedures, and critically, did not properly review critical documentation from their contract manufacturer including formulations, batch records, and certificates of analysis to verify required testing for methanol and acceptable levels of impurities like benzene, acetaldehyde, and acetal in ethanol components. These deficiencies rendered their drug products adulterated under federal law, violating 21 CFR parts 210 and 211. The FDA inspection occurred from July 24 to August 3, 2023, following which the company submitted a response on August 24, 2023.