Yara Elena De La Garza Perez Nieto

Warning LetterOpen

Mr. Felix Eduardo De La Garza Owner Yara Elena De La Garza Perez Nieto Gustavo V 179. Puertas Del Rey Saltillo 25298 Saltillo , Coah. MexicoFEI 3016680234Issued Feb 22, 2021Center for Drug Evaluation and Research | CDER

View Letter

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 3016680234.

Violations4

Issue DateFeb 22, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Yara Elena De La Garza Perez Nieto
Location: Mr. Felix Eduardo De La Garza Owner Yara Elena De La Garza Perez Nieto Gustavo V 179. Puertas Del Rey Saltillo 25298 Saltillo , Coah. Mexico
FEI Number: 3016680234
Country: Mexico
Issue Date: February 22, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Yara Elena De La Garza Perez Nieto, a Mexican drug manufacturer, was cited for producing DAESI Hand Sanitizer that was adulterated due to substance substitution and lacked adequate quality assurance controls required under Current Good Manufacturing Practice (CGMP). The product was also deemed an unapproved new drug and misbranded under multiple sections of the Federal Food, Drug, and Cosmetic Act, resulting in its detention and refusal of admission at the U.S. border. These violations represented prohibited introduction of unapproved and adulterated drugs into interstate commerce.

Yara Elena De La Garza Perez Nieto FDA Warning Letter, February 22, 2021