Precision Analitica Integral S.A. de C.V. Warning Letter Details

Summary

Precision Analitica Integral S.A. de C.V., a Mexican drug manufacturer, was cited for producing CleanCare nogerm ADVANCED HAND SANITIZER, an unapproved hand sanitizer product that was adulterated due to substance substitution and failed quality assurance controls in violation of Current Good Manufacturing Practice requirements. FDA laboratory testing of a batch detained at the U.S. border confirmed the product was adulterated under sections 501(d)(2) and 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act, and the product was also found to be misbranded and introduced into interstate commerce without approval under section 505(a).