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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 EK4-4503125-6/1/2


Manufacturer FEI3004124940
Manufacturer NameAbba Seafood Ab  
Manufacturer Address line 1P.O.Box 673  
Manufacturer Address line 2  
Manufacturer's CityUddevalla  
Manufacturer Province/State  
Manufacturer Country/AreaSweden  
Product Code16YEF99  
Importer's Product DescriptionSALMON FISH SPREAD - IN A TUBE - ABBA  
Refusal Date25-Dec-2003  
FDA DistrictCHI-DO  
Entry/doc/line/sfx EK4-4503125-6/1/2
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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