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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 JK8-0104778-3/60/3

Manufacturer FEI2000031630
Manufacturer NameNichirei Foods Inc.  
Manufacturer Address line 16-19-20,tsukiji,chuo-ku  
Manufacturer Address line 2Tokyo,Japan  
Manufacturer's Citychuo-ku  
Manufacturer Province/StateJP-13  
Manufacturer Country/AreaJapan  
Product Code38BDN16  
Refusal Date30-Apr-2003  
FDA DistrictLOS-DO  
Entry/doc/line/sfx JK8-0104778-3/60/3
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.