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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 U16-3913770-6/11/1

Manufacturer FEI3007164155
Manufacturer Address line 1Plot # M-1 Add. Ambernath MIDC  
Manufacturer Address line 2Anand Nagar, Ambernath (E)  
Manufacturer's CityKalyan  
Manufacturer Province/StateMaharashtra  
Manufacturer Country/AreaIndia  
Product Code53ID02  
Importer's Product DescriptionMUKHWAS(MOUTH FRESHNER)  
Refusal Date03-Jan-2012  
FDA DistrictCHI-DO  
Entry/doc/line/sfx U16-3913770-6/11/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
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).