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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 DS8-2804317-6/11/1

Manufacturer FEI3003537340
Manufacturer NameNihon Shokken Co Ltd.Ehime Plant  
Manufacturer Address line 15-26,Higashitoryu-Cho Imabari Ctiy  
Manufacturer Address line 2  
Manufacturer's CityEhime Pref  
Manufacturer Province/State  
Manufacturer Country/AreaJapan  
Product Code38NGT99  
FDA Product DescriptionCONCENTRATED BROTH, N.E.C.  
Refusal Date29-Apr-2003  
FDA DistrictLOS-DO  
Entry/doc/line/sfx DS8-2804317-6/11/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NEEDS FCE   402(a)(4), 801(a)(3); ADULTERATION   It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).  
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).  
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.  
NUTRIT LBL   403(q); 801(a)(3); Misbranding   The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.