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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 XXX-0165338-6/1/1/A


Manufacturer FEI3007474420
Manufacturer NameKolyeb company limited  
Manufacturer Address line 129 JONES NELSON ROAD ADABRAKA  
Manufacturer Address line 2  
Manufacturer's CityACCRA  
Manufacturer Province/StateGH-AA  
Manufacturer Country/AreaGhana  
Product Code16AFH99  
FDA Product DescriptionFISH, N.E.C.  
Refusal Date16-Sep-2009  
FDA DistrictBLT-DO  
Entry/doc/line/sfx XXX-0165338-6/1/1/A
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
INSANITARY   402(a)(4), 801(a)(3); ADULTERATION   The article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.  
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)]."  
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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