FDA Warns Michigan Drug Firm for Major CGMP Violations

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Kath Khemicals LLC, a Michigan-based manufacturer, following a March–April 2025 inspection. Published on November 4, 2025, the letter cites critical breaches of Current Good Manufacturing Practice (CGMP) under 21 CFR Parts 210 and 211. The company released OTC hand hygiene products without verifying identity, strength, or microbiological quality. It also failed to adequately test raw materials such as glycerin for diethylene glycol (DEG) and ethylene glycol (EG) contamination. The stability program was found insufficient, relying only on visual checks of samples without recorded data. Additionally, the Quality Unit lacked proper SOPs, documentation, and authority to ensure compliance. FDA directed the firm to establish validated testing methods, conduct full raw material identity testing, implement a sound stability program, and strengthen its Quality Unit oversight to achieve CGMP compliance.

13-11-2025