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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 906-0083375-1/7/1

Manufacturer FEI3000304718
Manufacturer NameVanka Kawat B.V.  
Manufacturer Address line 1Elbe 13-19  
Manufacturer Address line 2  
Manufacturer's CityLeidschendam  
Manufacturer Province/State  
Manufacturer Country/AreaNetherlands  
Product Code27YGE06  
FDA Product DescriptionPEPPER SAUCE (HOT, MILD, ETC.)  
Refusal Date05-Aug-2002  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 906-0083375-1/7/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.