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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 700-0769023-6/1/1


Manufacturer FEI3001744149
Manufacturer NameOpal Sy International Ltd  
Manufacturer Address line 1209 Moshav Bazra  
Manufacturer Address line 2  
Manufacturer's CityMoshav Bazra  
Manufacturer Province/State  
Manufacturer Country/AreaIsrael  
Product Code21GCE99  
Importer's Product DescriptionGRAPE LEAVES  
Refusal Date04-Aug-2002  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 700-0769023-6/1/1
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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