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Talk to a SpecialistTalk to a SpecialistTCT Nutraceuticals SDN. BHD, a Malaysia-based manufacturer of over-the-counter drug products including Antibacterial Hand Sanitizer Gel, failed to conduct required identity testing of incoming drug components prior to manufacturing, specifically failing to test the active ingredient isopropyl alcohol for methanol contamination, in violation of 21 CFR 211.84(d)(1). Without adequate component testing, the company could not provide scientific evidence that raw materials conformed to appropriate specifications before use in production. These manufacturing control failures rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.