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Talk to a SpecialistTalk to a SpecialistOmni Lens Pvt. Ltd., an OTC drug manufacturer in India, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in three drug products—Green Glo, BioGlo, and Vista Gonio Eye Lubricant—being deemed adulterated and misbranded. The company's quality control unit failed to ensure products met established specifications for identity, strength, quality, and purity, and the firm lacked an adequate quality unit to exercise appropriate procedures and controls over OTC drug manufacturing. The facility's non-conformance with CGMP requirements and failure to maintain proper registration rendered the manufactured drugs unsuitable for introduction into interstate commerce.