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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 EKX-0855013-3/1/1

Manufacturer FEI3008416932
Manufacturer NameSaffron Int'L Inc.  
Manufacturer Address line 19,Jungchi Road  
Manufacturer Address line 2  
Manufacturer's CityTaichung  
Manufacturer Province/State  
Manufacturer Country/AreaTaiwan  
Product Code53CK02  
Importer's Product DescriptionEYELINER - SPARKLER  
Refusal Date23-Apr-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx EKX-0855013-3/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).  
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