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Hygienic Labs, LLC, a manufacturer of over-the-counter drug products, was cited for refusing to provide access to and copying of records in violation of section 301(e) of the Federal Food, Drug, and Cosmetic Act. The company failed to respond to three separate records requests issued pursuant to section 704(a)(4) between September 2022 and February 2023, including electronic requests, phone contact attempts, and a written request delivered via UPS to its registered address. Due to the company's non-compliance, the FDA had no ability to assess the quality assurance standards for drugs manufactured at the facility. The firm was directed to respond within 48 hours to confirm its registration status and indicate whether it would comply with the outstanding records request.