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Talk to a SpecialistTalk to a SpecialistLightEyez Limited was cited for manufacturing and distributing MSM Eye Repair Drops, an over-the-counter ophthalmic drug product that FDA testing confirmed was adulterated due to containing filthy, putrid, or decomposed substance. The company's manufacturing methods, facilities, and controls failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals under 21 CFR Parts 210 and 211. FDA had conducted a meeting with the company on August 24, 2023, and reviewed their subsequent correspondence, which did not adequately address the manufacturing deficiencies identified during testing.