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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 112-3645820-0/6/1

Manufacturer FEI3003114603
Manufacturer NameKraft Foods Produktion Gmbhproduktions Gmbh & Co  
Manufacturer Address line 1Langemarkstr 4-20  
Manufacturer Address line 2  
Manufacturer's CityBremen  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code28CFT46  
Refusal Date05-Sep-2013  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-3645820-0/6/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIETARYLBL   403(s)(2)(B), 801(a)(3), misbranded   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term ?dietary supplement,? which term may be modified with the name of such an ingredient. [Misbranding, Section 403(s)(2)(B)].  
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.