FDA WARNING_LETTER - DEPQ Internacional S. de R.L de C.V. - March 23, 2021

The FDA issued a Warning Letter to DEPQ Internacional S. de R.L de C.V. (FEI 3016788198) after its hand sanitizer products (Cleanhumans Hand Sanitizer, dgreen ADVANCED HAND SANITIZER ANTIBACTERIAL GEL, and dgreen ADVANCED HAND SANITIZER Alcohol Free) were detained at the U.S. border. FDA testing revealed significant subpotency: ethanol-based products contained 1.5-1.7% ethanol instead of 60%, and BZK-based products had 0.7-1.5% BZK instead of 10%. These findings resulted in multiple violations: 1) Adulteration (501(c)): Products' strength, purity, and quality fell below claims. 2) Adulteration (501(a)(2)(B)): Subpotency indicated quality assurance failures and non-compliance with Current Good Manufacturing Practice (CGMP). 3) Unapproved New Drugs (505(a), 301(d)): Products are not Generally Recognized As Safe and Effective (GRASE), do not conform to applicable monographs or temporary COVID-19 policies, and contain unpermitted active ingredients. 4) Misbranding (502(a), 502(ee), 502(x)): Labeling was false/misleading on strength, failed to comply with nonprescription drug marketing requirements, and one product lacked a domestic adverse event reporting contact. The FDA recommends engaging a CGMP consultant and requires a written response within 15 working days detailing investigations into subpotency, raw materials, and corrective actions. All firm products are on Import Alert 66-78, preventing U.S. entry until compliance is verified, potentially via inspection.