Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistMaison Blanche LLC, a manufacturer of OTC hand sanitizer products, failed to comply with FDA's section 704(a)(4) records request spanning over a year from August 2022 through September 2023. The company did not respond to multiple electronic requests, phone calls, and voicemails requesting access to and copying of records, despite FDA's repeated attempts to contact them via email and telephone. This non-compliance constituted a prohibited act under section 301(e) of the Federal Food, Drug, and Cosmetic Act. The company's continued registration renewal did not include cooperation with the FDA's investigative records request.