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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-8400615-0/2/1

Manufacturer FEI1000161942
Manufacturer NameKryolan GmbH  
Manufacturer Address line 1Papierstrabe 10  
Manufacturer Address line 2  
Manufacturer's CityBerlin  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53GH02  
Importer's Product DescriptionPOWDER  
Refusal Date15-Nov-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-8400615-0/2/1
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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