FDA Issues Warning Letter to Kaylaan LLC

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 company manufactured and distributed batches of Kaylaan Toothpaste Tablets with Fluoride since 2021 without testing. 

• Failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength and quality. FDA maintained Kaylaan also failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

• Failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).

• Failed to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality and purity they purport or are represented to possess. FDA maintains Kaylaan also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.100(a) and 211.67(b)).

• Failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair (21 CFR 211.58).

Based upon the nature of the violations identified at Kaylaan, FDA advised engaging a consultant qualified as set forth in 21 CFR 211.34 to assist in meeting CGMP requirements before continuing drug manufacturing and distribution operations. The qualified consultant should also perform a comprehensive six-system audit of the entire operation for CGMP compliance and evaluate the completion and efficacy of all CAPAs before pursuing resolution of its compliance status per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.