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Talk to a SpecialistTalk to a SpecialistColorful Products Corporation failed to maintain Current Good Manufacturing Practice (CGMP) standards for its over-the-counter topical drug products and hand sanitizers, rendering them adulterated. The company's quality control unit did not adequately oversee manufacturing operations, specifically failing to perform and review testing for active ingredient identity and strength before batch release, conduct thorough investigations of out-of-specification results and complaints, document production changes, and establish a proper stability program. The FDA issued this warning after inspecting the facility in November 2021 and received no response to the Form FDA 483 observations documenting these violations.