KM Pharmaceutical Co. Ltd. – FDA Warning Letter, Aug 8, 2023

KM Pharmaceutical Co. Ltd., a South Korean manufacturer of OTC drug products, including (b)(4) and hand sanitizer, is registered with the FDA. The firm's products contain ingredients susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) substitution, which are associated with lethal poisoning incidents. The FDA issued multiple electronic and written requests for records and other information under section 704(a)(4) of the FD&C Act, starting March 3, 2023. KM Pharmaceutical failed to respond to any of these requests or associated communication attempts. This failure constitutes a prohibited act under section 301(e) of the FD&C Act, as it is a refusal to permit access to records required by section 704(a). Due to the lack of response, the FDA has no indication of the firm's quality assurance level for its drug products. Consequently, the FDA may withhold approval of new applications listing KM Pharmaceutical as a manufacturer, and shipments of their drug products into the U.S. are subject to detention or refusal under section 801(a)(3). All drugs from the firm were placed on Import Alert 66-79 on June 7, 2023. The firm must respond in writing within 15 working days, providing information or requesting an inspection, to address these serious compliance issues.