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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.