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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 KM6-0052402-9/3/13

Manufacturer FEI3008480498
Manufacturer NameWipro Ltd  
Manufacturer Address line 1A-1 Plot No. 77 Epip Phase, J  
Manufacturer Address line 2  
Manufacturer's CityTehsil Nagagor  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53JY01  
Importer's Product DescriptionSANTOOR TOILET SOAP  
Refusal Date10-Nov-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx KM6-0052402-9/3/13
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).  
COSMETLBLG   5(c)(3)(A); 801(a)(3) Misbranding   It appears the label does not bear the common or usual name of the cosmetic.  
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
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