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

Warning LetterOpen

Mr. Eduardo Romero President and Owner Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V. Avenida de la Unidad No. 100, Local 6 Colonia Valle de Infonavit 64350 Monterrey , N.L. MexicoFEI 3016735321Issued Feb 22, 2021Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016735321.

Violations3

Issue DateFeb 22, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V.
Location: Mr. Eduardo Romero President and Owner Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V. Avenida de la Unidad No. 100, Local 6 Colonia Valle de Infonavit 64350 Monterrey , N.L. Mexico
FEI Number: 3016735321
Country: Mexico
Issue Date: February 22, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

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.

Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V. FDA Warning Letter, February 22, 2021