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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 KR4-0044414-6/4/2


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 Code53LC07  
FDA Product DescriptionNIGHT (SKIN CARE PREPARATIONS)  
Refusal Date02-Nov-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx KR4-0044414-6/4/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
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