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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 WPK-0150463-5/5/1

Manufacturer FEI3004254063
Manufacturer NameAl Kanater S.A.L.  
Manufacturer Address line 1Mkalles - Main Road - Behind  
Manufacturer Address line 2Dantziguian - Abou Naoum Building  
Manufacturer's CityMkalles Beirut  
Manufacturer Province/StateLB-BA  
Manufacturer Country/AreaLebanon  
Product Code25RCE99  
Importer's Product DescriptionTRUFFLES IN OIL  
Refusal Date02-Aug-2002  
FDA DistrictFLA-DO  
Entry/doc/line/sfx WPK-0150463-5/5/1
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.