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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 AGT-0006434-6/15/1


Manufacturer FEI3007050844
Manufacturer NameSun Mark Ltd.  
Manufacturer Address line 1Sun House 428 Long Drivegreenford  
Manufacturer Address line 2  
Manufacturer's CityMiddlesex  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code25YFT99  
Importer's Product DescriptionBAKED BEENS  
Refusal Date10-Sep-2010  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AGT-0006434-6/15/1
FDA Sample AnalysisNo  
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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