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Gulf States International, Inc., a manufacturer of over-the-counter drug products, failed to respond to FDA records requests issued under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act on multiple occasions between September 2022 and September 2023, despite follow-up communications via email and phone. The company's refusal to provide access to and copying of manufacturing records constituted a prohibited act under section 301(e) of the FD&C Act, leaving the FDA unable to assess the quality assurance levels for drugs manufactured at the facility. The FDA provided the company 48 hours to confirm its registration status and indicate willingness to comply with the records request, or alternatively to delist all previously registered drugs and deregister the facility.