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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 E8P-0003150-1/1/1


Manufacturer FEI3009131322
Manufacturer NameCiencia Cosmetica S.A. De C.V.  
Manufacturer Address line 1Norte 81 # 565col. San Sebastian  
Manufacturer Address line 2  
Manufacturer's CityAzcapotzalcomexico Distrito Federal  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LC99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date24-Oct-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx E8P-0003150-1/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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