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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 K74-0163384-0/31/1


Manufacturer FEI3007393544
Manufacturer NameHarika Foods & Innovations Ltd  
Manufacturer Address line 1Daisy 43 Serene Country  
Manufacturer Address line 2  
Manufacturer's CityHyderabad  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53CY02  
Importer's Product DescriptionEYETEX (EYELINER)  
Refusal Date03-May-2012  
FDA DistrictCHI-DO  
Entry/doc/line/sfx K74-0163384-0/31/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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.  
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
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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