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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 BGK-0387994-8/68/1

Manufacturer FEI3009433601
Manufacturer NameAl Shaikh Enterprises  
Manufacturer Address line 1V-E-2/6 First Floor Paposh Nagar  
Manufacturer Address line 2Nazimabad  
Manufacturer's CityKarachi  
Manufacturer Province/StateSindh  
Manufacturer Country/AreaPakistan  
Product Code53YH99  
Importer's Product DescriptionEYE LINER, 10 STICKS, 6X20: 5 CASES  
Refusal Date30-May-2012  
FDA DistrictDET-DO  
Entry/doc/line/sfx BGK-0387994-8/68/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).