Regulations

FDA Issues Warning Letter to Kaylaan LLC

Cites manufacturing procedures for Kaylaan Toothpaste Tablets with Fluoride.

The US Food and Drug Administration issued a Warning Letter to Kaylaan LLC, Floral Park, NY, after finding violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Specifically, FDA found Kaylaan: • Failed to perform release testing of batches of Kaylaan Toothpaste Tablets with Fluoride. During the inspection, Kaylaan stated no finished product release testing was conducted for identity and strength of the active ingredient. According to FDA, the c...

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