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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 823-0090947-8/9/1


Manufacturer FEI3004351846
Manufacturer NameBaktat Gida San. Ve. Tic. Ltd. Sti.  
Manufacturer Address line 1Yalova Yolu Derince Mevkii 2.Km No:19  
Manufacturer Address line 2  
Manufacturer's CityGemlik  
Manufacturer Province/StateTR-16  
Manufacturer Country/AreaTurkey  
Product Code21HET09  
Importer's Product DescriptionOLIVES LINED  
Refusal Date27-Aug-2002  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 823-0090947-8/9/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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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