Maquiladora Miniara SA de CV – FDA Warning Letter, Dec 15, 2021

On December 15, 2021, the FDA issued a Warning Letter to Maquiladora Miniara S.A. de C.V., a registered human drug manufacturer, following the detention and refusal of Shine and clean Hand Sanitizer Gel imports into the U.S. FDA testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained significantly lower ethanol concentrations (e.g., 2.2%, 1.0%, 49%, 1%) and high levels of undeclared methanol (e.g., 43%, 77%, 3.3%, 75%) and isopropanol.

This substitution of active ingredients with dangerous chemicals like methanol renders the product adulterated under section 501(d)(2) of the FD&C Act. The presence of methanol, a toxic substance, also indicates a failure of the firm's quality assurance system to comply with Current Good Manufacturing Practice (CGMP) requirements, violating section 501(a)(2)(B).

Furthermore, Shine & clean Hand Sanitizer Gel is an unapproved new drug under section 505(a) and misbranded under sections 502(j), (a), (e), (x), and (ee) of the FD&C Act. It is dangerous to health due to methanol, its labeling is false/misleading regarding ethanol content and undeclared methanol