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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 KM6-0052402-9/1/11

Manufacturer FEI3004526363
Manufacturer NameDey'S Medical Stores Pvt Ltd.,  
Manufacturer Address line 1542 Anandapur  
Manufacturer Address line 2  
Manufacturer's CityKolkata  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53ED99  
Importer's Product DescriptionKEO KARPIN HAIR OIL  
Refusal Date10-Nov-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx KM6-0052402-9/1/11
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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.