Plasticos Las Palmas, S.A. de C.V – FDA Warning Letter, Mar 1, 2021

The FDA issued a Warning Letter to Plasticos Las Palmas S.A. de C.V. on March 1, 2021, following the detention and refusal of admission of their MEDICALLY MINDED Hand Sanitizer Gel at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethyl alcohol, actually contained an average of 0.84% ethanol and 54% methanol.

This constitutes adulteration under section 501(d)(2) of the FD&C Act due to the substitution of ethanol with dangerous methanol, and under 501(a)(2)(B) for demonstrating a non-functioning quality assurance system. The product is also an unapproved new drug, violating section 505(a), and is misbranded under sections 502(j), (a), (e), (x), and (ee) for being dangerous, having false labeling, failing to list all ingredients, lacking a domestic contact, and not complying with nonprescription drug marketing requirements.

The FDA recommended engaging a qualified CGMP consultant to evaluate operations and assist with compliance. All firm-manufactured drugs were placed on Import Alert 66-78 on August 6, 2020. The company must respond within 15 working days detailing corrective actions and prevention plans.