Plasticos Las Palmas, S.A. de C.V

Warning LetterOpen

Sergio Akira Gonzalez Uyeda Plasticos Las Palmas, S.A. de C.V Vereda de las Violetas 19 45640 Tlajomulco de Zuñiga , Jal. MexicoFEI 3016851785Issued Mar 1, 2021Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016851785.

Violations3

Issue DateMar 1, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Plasticos Las Palmas, S.A. de C.V
Location: Sergio Akira Gonzalez Uyeda Plasticos Las Palmas, S.A. de C.V Vereda de las Violetas 19 45640 Tlajomulco de Zuñiga , Jal. Mexico
FEI Number: 3016851785
Country: Mexico
Issue Date: March 01, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

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.

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