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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 H67-1389980-4/25/3

Manufacturer FEI3008459891
Manufacturer NamePankaj Exports  
Manufacturer Address line 1Plot No. 419, TTC Industrial Area, MIDC  
Manufacturer Address line 2Mahaphe MIDC Road, Turbhe  
Manufacturer's CityNavi Mumbai  
Manufacturer Province/StateIN-MH  
Manufacturer Country/AreaIndia  
Product Code53CY02  
Refusal Date07-May-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx H67-1389980-4/25/3
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).