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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 GX5-9927090-5/25/4

Manufacturer FEI3004714518
Manufacturer NameNisa International  
Manufacturer Address line 1Adam Smith Street  
Manufacturer Address line 2  
Manufacturer's CityGrimsby  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code53JD01  
Importer's Product DescriptionSOAP COAL TAR  
Refusal Date21-Jun-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx GX5-9927090-5/25/4
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).