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Talk to a SpecialistTalk to a SpecialistEzriCare LLC received a warning for distributing adulterated artificial tear eye drops 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 and held under insanitary conditions that could have caused contamination with filth or rendered them injurious to health. Additionally, the artificial tears product was misbranded in violation of the Federal Food, Drug, and Cosmetic Act. The warning was issued following an FDA inspection in March 2023 that revealed significant CGMP violations at the foreign manufacturing facility, which was linked to a Pseudomonas aeruginosa outbreak detected in December 2022.