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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  
FDA Product DescriptionPIT FRUIT, N.E.C.  
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  
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.