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GTP International Corp, a manufacturer of over-the-counter hand sanitizer products, failed to provide access to and copying of records requested by the FDA pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. Despite multiple contact attempts between August 2022 and August 2023—including two email requests, a phone call with a voicemail, and certified mail—the company did not respond to or provide the requested records and information. This refusal constituted a prohibited act under section 301(e) of the FD&C Act, leaving the FDA without information to assess the quality assurance of drugs manufactured at the facility. The FDA demanded a response within 48 hours confirming registration and drug listing status and indicating whether the company would comply with the records request.