Simex Logistics S.A. de C.V.

Warning LetterOpen

Mr. Jose Ambrosio Rodriguez CEO Simex Logistics S.A. de C.V. Salvatierra No. 101 Fracc. El Puente 38060 Celaya , Gto. MexicoFEI 3016774460Issued Jan 28, 2021Center for Drug Evaluation and Research | CDER

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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 3016774460.

Violations3

Issue DateJan 28, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Simex Logistics S.A. de C.V.
Location: Mr. Jose Ambrosio Rodriguez CEO Simex Logistics S.A. de C.V. Salvatierra No. 101 Fracc. El Puente 38060 Celaya , Gto. Mexico
FEI Number: 3016774460
Country: Mexico
Issue Date: January 28, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Simex Logistics S.A. de C.V., a Mexican drug manufacturer, was cited for producing HEALTH & HAND GEL HAND SANITIZER, an unapproved new drug that was adulterated due to subpotency and inadequate quality assurance controls failing to meet Current Good Manufacturing Practice (CGMP) requirements. FDA laboratory testing of a detained batch revealed the product's strength, purity, and quality fell below represented levels, and the product was also found to be misbranded. The company violated multiple sections of the Federal Food, Drug, and Cosmetic Act by introducing an unapproved drug into interstate commerce without authorization.

Simex Logistics S.A. de C.V. FDA Warning Letter, January 28, 2021