Yara Elena De La Garza Perez Nieto Warning Letter Details

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.