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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal ETK-0001719-1/1/1/A

Manufacturer FEI3008256787
Manufacturer NameQuality Colors And Creams S.a. De C.v.  
Manufacturer Address line 1Av. Estado De Mexico No. 3 Col.  
Manufacturer Address line 2Cristobal Higuera  
Manufacturer's CityAtizapan De Zaragoza Edo. De Mexico  
Manufacturer Province/StateMexico  
Manufacturer Country/AreaMexico  
Product Code53LD99  
Importer's Product DescriptionASSORTED SKIN CARE PRODUCTS  
Refusal Date24-Jan-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx ETK-0001719-1/1/1/A
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.