Quimica Magna de Mexico, S.A. de C.V. – FDA Warning Letter, Oct 15, 2020

On October 15, 2020, the FDA issued a Warning Letter to Quimica Magna de Mexico, S.A. de C.V., a registered human drug manufacturer. The letter details violations concerning Datsen Hand Sanitizer and Alcohol Antiseptic 62% Topical Solution Hand Sanitizer products.

FDA testing of detained products revealed significant subpotency: Datsen Hand Sanitizer, labeled at 75% v/v ethanol, contained only 15% v/v, and Alcohol Antiseptic 62% Topical Solution Hand Sanitizer, labeled at 62% v/v ethanol, contained only 50% v/v. These levels are below the CDC-recommended minimum of 60% ethanol for hand sanitizers.

These products are deemed adulterated under section 501(c) of the FD&C Act due to their strength, purity, or quality falling below represented levels, and under section 501(a)(2)(B) for demonstrating a failure in quality assurance and non-compliance with Current Good Manufacturing Practice (CGMP) requirements.

Furthermore, the products are unapproved new drugs, violating section 505(a) of the FD&C Act, as they are not generally recognized as safe and effective (GRASE) and lack FDA approval. They are also misbranded under sections 502(a) and (ee)