FDA WARNING_LETTER - Precision Analitica Integral S.A. de C.V. - February 05, 2021

This FDA Warning Letter, dated February 5, 2021, targets Precision Analitica Integral, a Mexican human drug manufacturer, concerning its CleanCare nogerm ADVANCED HAND SANITIZER. FDA testing of a product batch detained at the U.S. border revealed severe adulteration: the product, labeled for 75% ethyl alcohol, contained only 40% ethyl alcohol and 28% methanol, a toxic substance. This substitution constitutes adulteration under FD&C Act sections 501(d)(2) and 501(a)(2)(B), demonstrating a critical failure in Current Good Manufacturing Practice (CGMP) quality assurance. The hand sanitizer is also an unapproved new drug, violating section 505(a) of the FD&C Act, as it lacks FDA approval and does not conform to OTC monographs or temporary COVID-19 policies. It is misbranded under sections 502(j), (a), (e), (x), and (ee) for being dangerous due to methanol, having false labeling, failing to declare methanol, lacking a domestic contact for adverse events, and non-compliance with section 505G marketing requirements. The FDA demands a detailed investigation into testing failures, lists of raw materials/suppliers, batch reconciliations, complete batch records, and supplier qualification program details. Engaging a CGMP consultant is strongly recommended. All firm products are on Import Alert 66-78. A response detailing corrective actions is required within 15 working days.