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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 J34-0065822-8/2/1

Manufacturer FEI3004203292
Manufacturer NameMacaroni Factory Development Co. Ltd. Of Xinhui District  
Manufacturer Address line 128 Chengdong Road, Huicheng Town, Xinhui  
Manufacturer Address line 2  
Manufacturer's CityJiang Men City  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code04CGT99  
Refusal Date03-Nov-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx J34-0065822-8/2/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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)].