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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-0001597-1/1/1/D

Manufacturer FEI3009752200
Manufacturer NameZermat Internacional Sa De Cv  
Manufacturer Address line 1Calzada Melchor Ocampo 193 Torre 3 Piso  
Manufacturer Address line 2  
Manufacturer's CityMexico Df  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LD99  
Importer's Product DescriptionASSORTED SKIN CARE PRODUCTS  
Refusal Date16-Nov-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx ETK-0001597-1/1/1/D
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.