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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  
Importer's Product DescriptionNOODLE SOUP(MENTSUYU TOKUSEN)  
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  
Charge(s)
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   It appears that the manufacturer has not filed information on its scheduled process as required by 21 CFR 108.25(c)(2) or 108.35(c)(2).  
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.  
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