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Talk to a SpecialistTalk to a SpecialistThe Tranzonic Companies/Innocore Sales & Marketing Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of over-the-counter drug products at their Woodstock, Ontario facility. The company failed to conduct adequate finished product release testing for each batch, specifically failing to test for identity and strength of active ingredients and to screen for objectionable microorganisms prior to release, in violation of 21 CFR 211.165(a) and (b). These deficiencies resulted in the company's drug products being deemed adulterated under the Federal Food, Drug, and Cosmetic Act because their manufacturing methods, facilities, and controls did not conform to required standards.