DEPQ Internacional S. de R.L de C.V. Warning Letter Details

Summary

DEPQ Internacional S. de R.L de C.V., a Mexican drug manufacturer, was warned for manufacturing three hand sanitizer products (Cleanhumans Hand Sanitizer, dgreen ADVANCED HAND SANITIZER ANTIBACTERIAL GEL, and dgreen ADVANCED HAND SANITIZER Alcohol Free) that were adulterated due to subpotency—meaning their active ingredient strength fell below claimed levels—and violated Current Good Manufacturing Practice (CGMP) requirements. The products were also unapproved new drugs introduced into U.S. interstate commerce without required FDA approval and were misbranded. FDA testing of batches detained at the U.S. border confirmed these compliance failures related to product strength, purity, and quality assurance deficiencies.