FDA 483 - Kaylaan LLC - March 01, 2024

Kaylaan LLC, an OTC manufacturer located in Floral Park, NY, underwent an FDA inspection from February 14 to March 1, 2024. The inspection revealed significant compliance issues with Current Good Manufacturing Practices (CGMP). Key observations included the absence of a quality control unit, which led to deficiencies in complaint handling, annual product reviews, discrepancy investigations, and employee training. Additionally, the firm failed to conduct necessary testing to verify the identity and strength of active ingredients in their Kaylaan Toothpaste Tablets with Fluoride before distribution.

Further violations included inadequate testing of raw materials and excipients, lack of equipment qualification and calibration, and absence of validated manufacturing and packaging processes. The firm also did not establish written procedures for production and process controls, nor did it conduct cleaning validation studies for equipment used in manufacturing. These lapses could potentially compromise the identity, quality, and purity of the products.

The FDA requires Kaylaan LLC to address these issues by establishing a robust quality control unit, implementing comprehensive testing protocols, validating manufacturing processes, and ensuring equipment is properly maintained and calibrated. Immediate corrective actions are necessary to comply with regulatory standards and ensure product safety and efficacy.