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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  
FDA Product DescriptionHARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)  
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 article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor [Misbranded, Section 403 (e)(1)].  
LACKS N/C   403(e)(2), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act [Misbranded, Section 403 (e)(2)].  
LIST INGRE   403(i)(2), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. [Misbranded, Section 403(i)(2)]."  
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   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be [Misbranded, Section 403(i)(1)].  
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