Mr. Guillermo Jose Duarte
Owner
Tropicosmeticos SA de CV
Av. Via Morelos No. 60
Bodega 9 Rustica Xalostoc
55340 Ecatepec De Morelos , Méx.
MexicoFEI 3016764173Issued Aug 10, 2021Center for Drug Evaluation and Research
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 3016764173.
Violations4
Issue DateAug 10, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Tropicosmeticos SA de CV
Location
Mr. Guillermo Jose Duarte
Owner
Tropicosmeticos SA de CV
Av. Via Morelos No. 60
Bodega 9 Rustica Xalostoc
55340 Ecatepec De Morelos , Méx.
Mexico
FEI Number
3016764173
Country
Mexico
Issue Date
August 10, 2021
Issuing Office
Center for Drug Evaluation and Research
Product Type
Drugs
Status
Open
Summary
Tropicosmeticos SA de CV was warned for manufacturing Britz Hand Sanitizer, an unapproved new drug that was adulterated and misbranded in violation of federal law. FDA laboratory testing of a batch detained at the U.S. border revealed that the product's active ingredient (ethyl alcohol) was substituted wholly or in part, demonstrating failures in the company's quality assurance and Current Good Manufacturing Practice (CGMP) compliance. The product was labeled to contain 70% ethanol but did not meet this specification, and it lacked required FDA approval for introduction into interstate commerce.
Tropicosmeticos SA de CV FDA Warning Letter, August 10, 2021
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