Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistOmega Tech Labs LLC manufactured a combination drug-device product without complying with Current Good Manufacturing Practice (CGMP) regulations under 21 CFR parts 210 and 211, resulting in an adulterated product. Additionally, the company produced an unapproved new drug that lacked the required FDA approval under section 505(a) of the Federal Food, Drug, and Cosmetic Act, making its introduction into interstate commerce prohibited. The violations were identified during an FDA inspection conducted January 17-22, 2024, at the company's Boise, Idaho facility, with deficiencies in the methods, facilities, and controls used for manufacturing, processing, packing, and holding the products.