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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 BUS-0002118-6/151/1


Manufacturer FEI3004387264
Manufacturer NameMORINAGA & CO.,LTD.  
Manufacturer Address line 15-33-1 Shiba  
Manufacturer Address line 2Minato-ku  
Manufacturer's CityTOKYO  
Manufacturer Province/State  
Manufacturer Country/AreaJapan  
Product Code09CHT03  
Importer's Product DescriptionSWEET CONDENSED MILK IN PLASTIC TUBE  
Refusal Date04-Dec-2006  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BUS-0002118-6/151/1
FDA Sample AnalysisNo  
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 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).  
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