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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 KT5-0276092-1/2/3


Manufacturer FEI3003469685
Manufacturer NameNirvel Cosmetics S.L.  
Manufacturer Address line 1Pol. Ind. Cotes C/F/No 9  
Manufacturer Address line 2  
Manufacturer's CityAlcoi  
Manufacturer Province/State  
Manufacturer Country/AreaSpain  
Product Code53YD99  
FDA Product DescriptionOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.  
Refusal Date22-Oct-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx KT5-0276092-1/2/3
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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