Gaza Proveedora De Servicios De Hospedaje Y Alimentacion

Warning LetterOpen

Mr. Luis Armando Garcia Olivares CEO Gaza Proveedora De Servicios De Hospedaje Y Alimentacion Calle Castille 1473-A Colonia Jardines de la Reyna 45410 Tonala , Jal. MexicoFEI 3016808324Issued Mar 1, 2021Center for Drug Evaluation and Research | CDER

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Violations2

Issue DateMar 1, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Gaza Proveedora De Servicios De Hospedaje Y Alimentacion
Location: Mr. Luis Armando Garcia Olivares CEO Gaza Proveedora De Servicios De Hospedaje Y Alimentacion Calle Castille 1473-A Colonia Jardines de la Reyna 45410 Tonala , Jal. Mexico
FEI Number: 3016808324
Country: Mexico
Issue Date: March 01, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Gaza Proveedora De Servicios De Hospedaje Y Alimentacion, a Mexican drug manufacturer, was cited for manufacturing Pristine Hand Sanitizer Gel, an unapproved new drug that was adulterated and misbranded. FDA laboratory testing of a detained batch found the product was subpotent, demonstrating failures in quality assurance and non-compliance with Current Good Manufacturing Practice (CGMP) requirements. The product violated multiple provisions of the Federal Food, Drug, and Cosmetic Act, including unauthorized introduction of an unapproved new drug into interstate commerce and improper labeling claims.

Gaza Proveedora De Servicios De Hospedaje Y Alimentacion FDA Warning Letter, March 1, 2021