Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistBiotek India, an OTC drug manufacturer in India, violated current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and distributed unapproved isopropyl rubbing alcohol products into the United States without adequate testing. The company failed to perform appropriate laboratory testing to confirm that each batch of drug product met final specifications for identity and strength of active ingredients prior to release, in violation of 21 CFR 211.165(a). The distributed products were deemed adulterated and misbranded, with introduction into interstate commerce prohibited under the Federal Food, Drug, and Cosmetic Act.