FDA WARNING_LETTER - Medical Chemical Corporation - February 18, 2025

The FDA issued a warning letter to Medical Chemical Corporation, located at 19430 Van Ness Avenue, Torrance, following an inspection from February 12 to 18, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, as outlined in Title 21 CFR parts 210 and 211. The company"s drug products were found to be adulterated under section 501(a)(2)(B) of the FD&C Act due to non-compliance in manufacturing, processing, packing, or holding practices.

Key violations included the failure to conduct identity tests on each component of drug products, inadequate validation of suppliers" test analyses, and insufficient testing for methanol contamination in ethanol. Additionally, the company did not adequately test components at high risk for diethylene glycol or ethylene glycol contamination, such as glycerin, before use in manufacturing. The firm also failed to establish proper written procedures for production and process control, particularly concerning the water system used in manufacturing, which was not validated or monitored effectively for microbial contamination.

The FDA requires Medical Chemical Corporation to provide corrective actions, including comprehensive identity testing, validation of supplier analyses, and proper water system validation. The company must also address the potential impact of these violations on products currently in the U.S. market. Failure to comply with these requirements could result in further regulatory action.