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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 UPS-7829488-7/1/1/E

Manufacturer FEI3003995106
Manufacturer NameStargazer Products  
Manufacturer Address line 126 Progress Way  
Manufacturer Address line 2  
Manufacturer's CityCroydon  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code53GY11  
Importer's Product DescriptionFASHION CONTACT LENSES/DELV TIMOTHY THOMAS 16865 US HW 17 HAMPSTEAD,  
Refusal Date05-Oct-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-7829488-7/1/1/E
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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