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Kaylaan LLC, a drug manufacturer in Floral Park, NY, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection conducted in February-March 2024. The company failed to perform required release testing on batches of Kaylaan Toothpaste Tablets with Fluoride to verify the identity and strength of the active ingredient before distribution, manufacturing and distributing multiple batches since 2021 without any finished product or in-process testing. This manufacturing deficiency rendered the drug products adulterated under the Federal Food, Drug, and Cosmetic Act, as the company's methods, facilities, and controls did not conform to CGMP standards.