Distribuidora Lagunera del Norte S.A. de C.V.

Warning LetterOpen

Mr. Gerardo Pacheco Distribuidora Lagunera del Norte S.A. de C.V. Av Juarez #5735-5 27085 Torreón , Coah. MexicoFEI 3017394466Issued Mar 23, 2021Center for Drug Evaluation and Research

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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 3017394466.

Violations4

Issue DateMar 23, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Distribuidora Lagunera del Norte S.A. de C.V.
Location: Mr. Gerardo Pacheco Distribuidora Lagunera del Norte S.A. de C.V. Av Juarez #5735-5 27085 Torreón , Coah. Mexico
FEI Number: 3017394466
Country: Mexico
Issue Date: March 23, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

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.

Distribuidora Lagunera del Norte S.A. de C.V. FDA Warning Letter, March 23, 2021