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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 300-3647184-3/21/1


Manufacturer FEI3008872359
Manufacturer NameObson International Pvt. Ltd.  
Manufacturer Address line 13 Shastri Nagar Road  
Manufacturer Address line 2Bunglows, Andheri (W),  
Manufacturer's CityMumbai  
Manufacturer Province/StateMaharashtra  
Manufacturer Country/AreaIndia  
Product Code33EGT99  
Importer's Product DescriptionKUJA MISRI  
Refusal Date31-Aug-2010  
FDA DistrictCHI-DO  
Entry/doc/line/sfx 300-3647184-3/21/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
ALLERGEN   403(w) 801(a)(3); Misbranding   the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).  
LACKS FIRM   403(e)(1), 801(a)(3); MISBRANDING   The food is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.  
LACKS N/C   403(e)(2), 801(a)(3); MISBRANDING   The food is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regulations.  
LIST INGRE   403(i)(2), 801(a)(3); MISBRANDING   It appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.  
NUTRIT LBL   403(q); 801(a)(3); Misbranding   The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.  
TRANSFAT   403(q), 801(a)(3) ;MISBRANDING   The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].  
USUAL NAME   403(i)(1), 801(a)(3); MISBRANDING   It appears that the label does not bear the common or usual name of the food.  
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