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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 AYU-1001937-8/26/1


Manufacturer FEI3004653808
Manufacturer NameDONG-A OTSUKA CIRCULATION  
Manufacturer Address line 1498-3,Gamman-dong,Nam-gu  
Manufacturer Address line 2  
Manufacturer's CityBusan  
Manufacturer Province/StateKR-26  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code29YGY99  
FDA Product DescriptionSOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.  
Refusal Date09-Aug-2004  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AYU-1001937-8/26/1
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).  
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