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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 (Pvt) Ltd.  
Manufacturer Address line 1Veyangoda Rd., Urapola  
Manufacturer Address line 2  
Manufacturer's CityAtthanagalla  
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   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.  
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