Roque Plast S.A. de C.V. Warning Letter Details

Summary

Roque Plast S.A. de C.V. was warned for manufacturing an unapproved hand sanitizer product (COMMAND BRANDS GEL ANTIBAC INSTANT HAND SANITIZER) that was adulterated due to substitution of active ingredients and failed quality assurance controls, violating Current Good Manufacturing Practice requirements. The product was detained and refused admission at the U.S. border following FDA laboratory testing, which confirmed it did not contain the labeled 70% ethanol concentration. The firm also violated regulations prohibiting introduction of unapproved new drugs into interstate commerce and marketed the product as misbranded.