Distribuidora Lagunera del Norte S.A. de C.V. Warning Letter Details

Summary

Distribuidora Lagunera del Norte S.A. de C.V. manufactured weper Clean Solutions Hand Sanitizer, a topical antiseptic drug product that was found to be adulterated due to subpotency (failing to contain the labeled 70% active ingredient strength) and was marketed as an unapproved new drug in violation of federal law. FDA testing of a batch detained at the U.S. border revealed the product's strength, purity, or quality fell below representations, demonstrating that the facility's quality assurance procedures were not operating in compliance with Current Good Manufacturing Practice (CGMP) requirements. The product was also misbranded under multiple sections of the Food, Drug, and Cosmetic Act and its introduction into interstate commerce was prohibited.