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Zenzi Pharmaceutical Industries Pvt. Ltd., a contract manufacturer of prescription drug products, violated federal law by refusing to provide access to manufacturing records requested by the FDA. The company received three separate record requests between October 29 and November 15, 2024—via email and certified mail—but failed to respond or provide the requested documentation, including certificates of analysis and batch production records for injectable products shipped to the United States. The firm's Vice President of Quality contradicted customer records by falsely claiming the company did not manufacture the product in question, in direct violation of section 704(a) of the Federal Food, Drug, and Cosmetic Act. This refusal to comply with mandatory record access requirements constituted a prohibited act under section 301(e) of the FD&C Act.