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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 HA9-0500083-2/7/2


Manufacturer FEI1000616256
Manufacturer NameLanka Canneries Ltd.  
Manufacturer Address line 1Nawala Road, Narahenpita  
Manufacturer Address line 2Box 341  
Manufacturer's CityColombo  
Manufacturer Province/State  
Manufacturer Country/AreaSri Lanka  
Product Code16YCP99  
Importer's Product DescriptionMALDIVE FISH SAMBOL  
Refusal Date20-Dec-2005  
FDA DistrictLOS-DO  
Entry/doc/line/sfx HA9-0500083-2/7/2
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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