DMM Vission, S.A. de C.V.

Warning LetterOpen

Ma. de la Luz Escorza CEO DMM Vission, S.A. de C.V. Calle Lago Guija 234 Col. Agua Azul 57500 Ciudad Nezahualcoyotl , Méx. MexicoFEI 3016833130Issued Jun 3, 2021Center for Drug Evaluation and Research

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Violations4

Issue DateJun 3, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: DMM Vission, S.A. de C.V.
Location: Ma. de la Luz Escorza CEO DMM Vission, S.A. de C.V. Calle Lago Guija 234 Col. Agua Azul 57500 Ciudad Nezahualcoyotl , Méx. Mexico
FEI Number: 3016833130
Country: Mexico
Issue Date: June 03, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

DMM Vission, S.A. de C.V., a Mexican drug manufacturer, was cited for producing unapproved hand sanitizer products (SYP HEALTH HAND SANITIZER ALCOHOL GEL and Cleaner BY CRYSTALWARE HAND SANITIZER) that were detained at the U.S. border. FDA laboratory testing found the products were adulterated due to substance substitution and demonstrated failure of quality assurance systems to comply with Current Good Manufacturing Practice (CGMP) requirements. The products violated multiple provisions of the Federal Food, Drug, and Cosmetic Act, including regulations prohibiting unapproved new drugs and misbranded products lacking proper labeling and approval.

DMM Vission, S.A. de C.V. FDA Warning Letter, June 3, 2021