FDA 483 - Kaylaan LLC - March 01, 2024

Kaylaan LLC, an OTC drug manufacturer in Floral Park, NY, received a Form 483 with 13 observations highlighting severe deficiencies across its quality system and manufacturing operations. Key issues include the complete absence of a quality control unit, lack of essential testing (release, in-process, raw material identity, stability), unvalidated processes and equipment, inadequate documentation, and poor facility maintenance. These findings indicate a fundamental failure to adhere to CGMP requirements for its Kaylaan Toothpaste Tablets with Fluoride.