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Talk to a SpecialistTalk to a SpecialistDelsam Pharma LLC was cited for distributing adulterated ophthalmic drugs (Artificial Tears and Artificial Eye Ointment) manufactured by a contract manufacturer, Global Pharma Healthcare Private Limited, that violated Current Good Manufacturing Practice (CGMP) regulations under 21 CFR Parts 210 and 211. The products were prepared, packed, or held under insanitary conditions, creating risk of contamination with filth or substances injurious to health. Additionally, the products were misbranded under the Federal Food, Drug, and Cosmetic Act. The violations were identified following an FDA inspection of the foreign manufacturing facility in March 2023, which revealed significant CGMP deficiencies.