Grupo Plast-Y-Kosas, SA de CV Warning Letter Details

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.