Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V.

Warning LetterOpen

Mr. Francisco Cervantes Chief Executive Officer Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V. Privada Rio Atoyac No. 23 Colonia Rancho Colorado 72040 Puebla , Pue. MexicoFEI 3016821022Issued Jun 27, 2022Center 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 3016821022.

Violations3

Issue DateJun 27, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V.
Location: Mr. Francisco Cervantes Chief Executive Officer Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V. Privada Rio Atoyac No. 23 Colonia Rancho Colorado 72040 Puebla , Pue. Mexico
FEI Number: 3016821022
Country: Mexico
Issue Date: June 27, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Noticias Mexico Hoy Grupo Multimedia was cited for manufacturing Medical MARY CLEAN HAND Sanitizers, a hand sanitizer product that violated multiple FDA regulations including being an unapproved new drug, misbranded, adulterated, and failing to meet Current Good Manufacturing Practice (CGMP) requirements. FDA laboratory testing of a detained batch revealed that a substance was substituted wholly or in part for the declared 75% active ingredient, demonstrating deficient quality assurance controls at the facility. The product was detained and refused admission at the U.S. border following an attempted import.

Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V. FDA Warning Letter, June 27, 2022