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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 417-0277441-9/3/1


Manufacturer FEI3004879469
Manufacturer NameXiamen Da Chang Hua Import & Export Co., Ltd.  
Manufacturer Address line 11173 Building A, Jianye Building  
Manufacturer Address line 2North Hubing  
Manufacturer's CityXiamen  
Manufacturer Province/StateFujian  
Manufacturer Country/AreaChina  
Product Code33CGT13  
FDA Product DescriptionROCK CANDY, HARD, WITH FRUIT (WITHOUT CHOCOLATE)  
Refusal Date23-Nov-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 417-0277441-9/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis Yes  
Charge(s)
Violation Code Section Charge Statement
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)]."  
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)].  
UNSAFE COL   402(c), 801(a)(3); ADULTERATION   The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).  
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