Roque Plast S.A. de C.V.

Warning LetterOpen

Mr. Roque Cabrera Owner Roque Plast S.A. de C.V. Cerrada Adolfo Manfredi 7 C Atizapan De Zaragoza 52968 , MexicoFEI 3008251335Issued Apr 9, 2021Center for Drug Evaluation and Research

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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 3008251335.

Violations3

Issue DateApr 9, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Roque Plast S.A. de C.V.
Location: Mr. Roque Cabrera Owner Roque Plast S.A. de C.V. Cerrada Adolfo Manfredi 7 C Atizapan De Zaragoza 52968 , Mexico
FEI Number: 3008251335
Country: Mexico
Issue Date: April 09, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

Roque Plast S.A. de C.V. was warned for manufacturing an unapproved hand sanitizer product (COMMAND BRANDS GEL ANTIBAC INSTANT HAND SANITIZER) that was adulterated due to substitution of active ingredients and failed quality assurance controls, violating Current Good Manufacturing Practice requirements. The product was detained and refused admission at the U.S. border following FDA laboratory testing, which confirmed it did not contain the labeled 70% ethanol concentration. The firm also violated regulations prohibiting introduction of unapproved new drugs into interstate commerce and marketed the product as misbranded.

Roque Plast S.A. de C.V. FDA Warning Letter, April 9, 2021