Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V. Warning Letter Details

Summary

Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V. was cited for manufacturing an unapproved hand sanitizer product (ARGENT Defense Group HAND SANITIZER) that was adulterated due to substance substitution and failed quality assurance controls that violated Current Good Manufacturing Practice requirements. The product was also found to be misbranded and introduced into interstate commerce without FDA approval, violations of sections 505(a), 502(j), 502(a), and 502(ee) of the Federal Food, Drug, and Cosmetic Act. The violation was discovered when FDA detained and tested a batch of the product at the U.S. border attempting importation.