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KM Pharmaceutical Co. Ltd., a manufacturer of over-the-counter drug products including hand sanitizers with ingredients susceptible to diethylene glycol (DEG) and ethylene glycol (EG) contamination, failed to provide access to and copying of records as required by FDA regulations. The company did not respond to multiple record requests sent via email on March 3 and March 16, 2023, followed by a written request on April 17, 2023, despite confirmed delivery. This refusal to permit record access violated section 301(e) of the Federal Food, Drug, and Cosmetic Act. The FDA's enforcement action was prompted by concerns about potential contamination with DEG or EG, substances that have caused lethal poisoning incidents worldwide.