FDA WARNING_LETTER - Grupo Insoma, S.A.P.I de CV - November 03, 2020

On October 23, 2020, the FDA issued a Warning Letter to Grupo Insoma, S.A.P.I. de C.V., a registered human drug manufacturer in Cuanutitlan, Mexico (FEI 3016750033). The letter followed the detention and refusal of "Hand Sanitizer Gel Unscented 70% Alcohol 1000Lts" at the U.S. border.

FDA laboratory testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained 0% ethanol and over 60% methanol. This constitutes adulteration under section 501(d)(2) of the FD&C Act due to substitution with a dangerous chemical. The substitution also indicates a failure of the firm's quality assurance system, violating CGMP requirements (section 501(a)(2)(B)).

Furthermore, the product is an unapproved new drug (section 505(a)) and misbranded under multiple sections (502(j), (a), (e), (f)(2), (x), and (ee)). It is dangerous due to methanol, falsely labeled regarding active ingredients, lacks required warnings, and omits a domestic contact for adverse event reporting.

The FDA noted the firm's U.S. agent agreed to a recall on August 5, 2020