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Daxal Cosmetics Private Limited, an Indian manufacturer of over-the-counter drug products including toothpaste containing ingredients susceptible to contamination with diethylene glycol (DEG) and ethylene glycol (EG), failed to comply with FDA record access requests issued on November 15, 2022, November 23, 2022, and December 3, 2022 pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. Despite confirmed delivery of the written requests and follow-up communications, the company refused to provide access to or copying of the requested records, which constitutes a prohibited act under section 301(e) of the FD&C Act. The FDA's enforcement action was prompted by multiple shipments of the company's drug products into the United States and concerns about DEG and EG contamination, which have historically caused lethal poisoning incidents worldwide.