FDA WARNING_LETTER - Mohawk Laboratories Division of NCH Corporation - January 31, 2023

The FDA issued a Warning Letter to Mohawk Laboratories, Division of NCH Corporation, for manufacturing adulterated over-the-counter (OTC) hand sanitizer drug products. The facility was registered until June 2022 and distributed products as recently as April 2022. FDA laboratory testing of three lots, and the firm's own testing of additional lots, revealed unacceptable levels of acetaldehyde and acetal impurities. These impurities, known contaminants of alcohol, exceeded the United States Pharmacopeia (USP) limit of 10 ppm, rendering the drug products adulterated under sections 501(a)(2)(B) and 501(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The letter states that the contamination demonstrates a failure of the facility's quality assurance to function in accordance with Current Good Manufacturing Practice (CGMP) requirements. Furthermore, the firm's manufacturing methods, facilities, or controls did not conform to CGMP. Specific deficiencies include the failure to establish a specification for acetaldehyde and acetal per 21 CFR 211.160(b) and the failure to conduct finished product testing for each batch as required by 21 CFR 211.165. The firm issued a voluntary nationwide recall in December 2022. FDA recommends engaging a qualified CGMP consultant (21 CFR 211.34) for a comprehensive audit if the firm intends to resume drug manufacturing. Mohawk Laboratories has committed to ceasing drug production at this facility. The firm must respond within 15 working days detailing corrective actions and prevention plans, or face potential regulatory actions including seizure, injunction, and impact on future approvals or contracts.