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Cergomex Imports, LLC, a manufacturer of OTC drug products including Sanetto Hands Sanitizer Gel, failed to respond to FDA records requests sent via email on August 16 and August 31, 2022, and subsequent phone contact attempts in October 2022 and August 2023. The company's refusal to provide access to and copying of records as required under section 704(a) of the Federal Food, Drug, and Cosmetic Act constituted a prohibited act under section 301(e) of the FD&C Act. Without access to these records, the FDA had no way to assess the quality assurance levels for drugs manufactured at the facility. The FDA directed the company to respond within 48 hours confirming its registration status and willingness to comply with the records request, or to delist all drugs and deregister its facility if manufacturing had ceased.