Plasticos Las Palmas, S.A. de C.V Warning Letter Details

Summary

Plasticos Las Palmas, S.A. de C.V. manufactured MEDICALLY MINDED Hand Sanitizer Gel, an unapproved antiseptic drug product that was detained at the U.S. border and found to be adulterated due to substance substitution, indicating failed quality assurance and non-compliance with Current Good Manufacturing Practice (CGMP) requirements. The product violated multiple regulations by being introduced into interstate commerce as an unapproved new drug and was misbranded under several sections of the Federal Food, Drug, and Cosmetic Act. FDA laboratory testing of a detained batch confirmed the adulteration, demonstrating that the company's quality assurance systems were not functioning according to regulatory standards.