FDA WARNING_LETTER - Kath Khemicals LLC - April 03, 2025

The FDA issued a Warning Letter to Kath Khemicals LLC on September 22, 2025, following an inspection from March 31 to April 3, 2025, at their Macomb, MI drug manufacturing facility. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations, specifically 21 CFR parts 210 and 211, indicating their drug products are adulterated.

Key violations include the company"s failure to adequately test finished drug products, such as McD Foaming Antibacterial Hand Soap and McD Anti-Microbial Handwash, for identity, strength, and microbial contamination before distribution. Additionally, they lacked appropriate microbiological testing for the water used in their manufacturing processes. The FDA found the company"s proposed corrective actions for finished product and water testing to be insufficient.

Another critical issue was the failure to conduct proper identity testing for incoming components, notably glycerin. The company"s methods did not include testing for hazardous impurities like diethylene glycol (DEG) and ethylene glycol (EG), which have been associated with severe poisoning incidents. The proposed plan for contract lab testing of glycerin was also deemed inadequate due to a lack of detailed procedures and a retrospective review.

Required actions from the FDA include providing comprehensive plans for chemical and microbial testing of all drug product batches, including a review of reserve samples, and establishing a robust water system monitoring program. Kath Khemicals LLC must also detail how each component lot will be tested for identity, strength, quality, and purity, particularly for high-risk ingredients, and outline their program for qualifying suppliers and contract testing facilities.