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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 KR4-0044414-6/4/1


Manufacturer FEI3003029000
Manufacturer NameJafra Manufactuing S.A. de C.V.  
Manufacturer Address line 1AV. La Estacada No.201  
Manufacturer Address line 2Parque Industrial Queretaro  
Manufacturer's CityQueretaro  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LD99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date02-Nov-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx KR4-0044414-6/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DRUG NAME   502(e)(1); 801(a)(3); Misbranding   The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.  
NO ENGLISH   502(c); 801(a)(3);Misbranding   Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)  
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