Kaylaan LLC – FDA Warning Letter, Mar 1, 2024

The FDA issued Warning Letter #681977 to Kaylaan LLC on August 19, 2024, following an inspection from February 14 to March 1, 2024. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Lack of Finished Product Release Testing:** Kaylaan LLC failed to perform identity and strength testing for over (b)(4) batches of Kaylaan Toothpaste Tablets with Fluoride since 2021, and no in-process testing was conducted. The firm's response was inadequate, lacking a procedure for ensuring quality prior to release and a retrospective risk assessment for distributed batches. 2. **Inadequate Component Testing:** The firm failed to test incoming raw materials, including the active ingredient sodium fluoride, relying solely on supplier Certificates of Analysis (COAs) without validation. The response was insufficient, lacking procedures for sampling, identity testing, establishing specifications, and qualifying vendors/contract labs. 3. **Deficient Quality Unit (QU):** Kaylaan LLC lacked an adequate QU and written quality procedures for oversight, stability studies, annual product reviews, and batch manufacturing. The response was inadequate, lacking written procedures and scientific data for product stability. 4. **Failure in Production and Process Control:** The firm lacked process validation for manufacturing OTC drug products and equipment qualification. Changes to the formula