Grupo Plast-Y-Kosas, SA de CV

Warning LetterOpen

Mr. Wenceslao Garcia Owner Grupo Plast-Y-Kosas, SA de CV Callejon Puebla 105-Co Col. Rodriguez 88630 Reynosa , Tamps. MexicoFEI 3016756400Issued Jan 25, 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 3016756400.

Violations3

Issue DateJan 25, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Grupo Plast-Y-Kosas, SA de CV
Location: Mr. Wenceslao Garcia Owner Grupo Plast-Y-Kosas, SA de CV Callejon Puebla 105-Co Col. Rodriguez 88630 Reynosa , Tamps. Mexico
FEI Number: 3016756400
Country: Mexico
Issue Date: January 25, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Grupo Plast-Y-Kosas, SA de CV, a Mexican drug manufacturer, was cited for producing adulterated hand sanitizer products that were detained at the U.S. border in January 2021. FDA testing revealed that M Hand Sanitizer contained substituted substances in violation of manufacturing standards, while Jalisco Paper Inc. Hand Sanitizer and O.K. Pharmacy Hand Sanitizer were subpotent, failing to meet their labeled strength and purity claims. The violations demonstrated that the company's quality assurance system was not functioning in compliance with Current Good Manufacturing Practice (CGMP) requirements.

Grupo Plast-Y-Kosas, SA de CV FDA Warning Letter, January 25, 2021