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

The FDA issued a Warning Letter to Eduardo De La Garza, a registered human drug manufacturer, regarding DAESI Hand Sanitizer. The product, labeled as containing 70% ethyl alcohol, was detained at the U.S. border. FDA testing revealed the product was adulterated under 21 U.S.C. 351(d)(2) because ethanol was wholly or partially substituted with methanol, a toxic substance. Additionally, the product was adulterated under 21 U.S.C. 351(a)(2)(B) due to quality assurance failures, evidenced by the methanol substitution and inconsistent manufacturing processes, including the presence of isopropanol.

The DAESI Hand Sanitizer is also an unapproved new drug, violating 21 U.S.C. 355(a), and is misbranded under 21 U.S.C. 352(j), (a), (e)(1)(A), and (ee). Misbranding violations include being dangerous to health due to methanol, false labeling regarding ethanol content and undeclared ingredients (methanol, isopropanol), failure to list all ingredients, and unauthorized use of the "FDA" logo.

The FDA recommended engaging a qualified CGMP consultant to evaluate operations and assist with compliance. All drugs from the firm were placed on Import Alert 66-78 on July 17, 2020. The