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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 224-2226787-6/3/1

Manufacturer FEI3002714021
Manufacturer NamePrzedsiebiorstwo Wielobranzowe  
Manufacturer Address line 1Smak Ul 93 A  
Manufacturer Address line 2  
Manufacturer's CityZory  
Manufacturer Province/State  
Manufacturer Country/AreaPoland  
Product Code25JEE25  
Importer's Product DescriptionPEARL ONION  
Refusal Date13-Aug-2002  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 224-2226787-6/3/1
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.