Ignacio Reyes Gonzalez

Warning LetterOpen

Ms. Rosa Yolanda Reyes Hernandez Ignacio Reyes Gonzalez Calle Independencia 416 Col. Los Puestos 45560 Tlaquepaque , Jal. MexicoFEI 3016931251Issued Jan 25, 2021Center for Drug Evaluation and Research | CDER

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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 3016931251.

Violations3

Issue DateJan 25, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Ignacio Reyes Gonzalez
Location: Ms. Rosa Yolanda Reyes Hernandez Ignacio Reyes Gonzalez Calle Independencia 416 Col. Los Puestos 45560 Tlaquepaque , Jal. Mexico
FEI Number: 3016931251
Country: Mexico
Issue Date: January 25, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Ignacio Reyes Gonzalez, a Mexican drug manufacturer, was cited for producing MEDICALLY MINDED Hand Sanitizer Gel that was found to be adulterated due to substitution of active ingredients and misbranded as an unapproved new drug. FDA laboratory testing of a batch detained at the U.S. border revealed that the product failed to meet Current Good Manufacturing Practice (CGMP) requirements, indicating deficient quality assurance systems at the facility. The product violated multiple sections of the Federal Food, Drug, and Cosmetic Act, including prohibitions on introducing unapproved drugs into interstate commerce and regulations requiring proper drug labeling.

Ignacio Reyes Gonzalez FDA Warning Letter, January 25, 2021