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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 BMW-0005909-1/6/1


Manufacturer FEI3005332769
Manufacturer NameKrautica Pharma Gmbh & Co Kg  
Manufacturer Address line 1Im Sundernkamp 7, D-32130 Enger  
Manufacturer Address line 2  
Manufacturer's CityEnger  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code33SEH99  
FDA Product DescriptionCANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)  
Refusal Date19-Sep-2006  
FDA DistrictNYK-DO  
Entry/doc/line/sfx BMW-0005909-1/6/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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 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.  
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.  
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.  
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