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Sangleaf Pharm., Co. Ltd., a South Korean manufacturer of OTC drug products including children's toothpaste containing ingredients susceptible to contamination with diethylene glycol (DEG) and ethylene glycol (EG), failed to respond to multiple FDA requests for records and information issued on December 14, 2022, January 11, 2023, and January 27, 2023, in violation of section 704(a)(4) of the FD&C Act. The company did not provide the requested records despite confirmed delivery of communications and follow-up contact attempts by telephone and email. This non-compliance was particularly concerning given that DEG and EG contamination in drug products has caused lethal poisoning incidents worldwide, and the FDA had identified multiple shipments of the company's drug products entering the United States.