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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 390-2362565-8/2/1


Manufacturer FEI3004176163
Manufacturer NameAssan Gida San Vetic  
Manufacturer Address line 136 Km Karayola  
Manufacturer Address line 2  
Manufacturer's CitySusurlik Balikesir  
Manufacturer Province/State  
Manufacturer Country/AreaTurkey  
Product Code24FCI07  
FDA Product DescriptionPEPPER, SWEET (FRUIT USED AS VEGETABLE)  
Refusal Date06-Jan-2005  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 390-2362565-8/2/1
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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