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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  
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  
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   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.