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Talk to a SpecialistTalk to a SpecialistZhao Qing Longda Biotechnology Co. Ltd., a Chinese manufacturer of over-the-counter drug products including children's toothpaste, refused to provide access to records and information requested by the FDA pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. The company explicitly stated on April 19, 2023, that it was "not prepared to allow the FDA to audit and inspect" its firm, despite multiple requests sent via email on March 17, April 6, and April 18, 2023, and a follow-up written request on April 28, 2023. This refusal violated section 301(e) of the FD&C Act, which prohibits refusing to permit access to or copying of required records. The FDA's inspection was prompted by concerns regarding potential contamination of the company's drug ingredients—particularly those susceptible to diethylene glycol and ethylene glycol substitution—which have caused lethal poisoning incidents globally.