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Talk to a SpecialistTalk to a SpecialistDr. Brite, LLC received a warning for manufacturing oral care and hand sanitizer products that violated Current Good Manufacturing Practice (CGMP) regulations, rendering their drug products adulterated. The FDA identified that the company's methods, facilities, and controls for manufacturing, processing, packing, and holding did not conform to CGMP standards (21 CFR parts 210 and 211). Additionally, five toothpaste and mouth spray products were marketed as unapproved new drugs in violation of FD&C Act sections 505(a) and 301(d), and six hand sanitizer products were found to be misbranded. The violations were discovered during an FDA inspection of the Fullerton, California facility conducted April 2-5, 2024.