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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 HE8-0106905-6/4/1


Manufacturer FEI3004349923
Manufacturer NameDONG YANG FOOD CO.  
Manufacturer Address line 125-63, JONGAM-DONG, SUNGBUK-KU  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/StateSEOUL  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code07YEI99  
Importer's Product DescriptionFISHING FEED-FISHING FOOD PURPOSE ONLY  
Refusal Date09-Aug-2010  
FDA DistrictLOS-DO  
Entry/doc/line/sfx HE8-0106905-6/4/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NEEDS FCE   402(a)(4), 801(a)(3); ADULTERATION   It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).  
NO PROCESS   402(a)(4), 801(a)(3); ADULTERATION   It appears that the manufacturer has not filed information on its scheduled process as required by 21 CFR 108.25(c)(2) or 108.35(c)(2).  
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