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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 U72-0516383-6/11/1/C

Manufacturer FEI3007272259
Manufacturer NameINDUSTRIA DE CAFE S.A  
Manufacturer Address line 16.5 KM CARRETERA AL ATLANTICO ZONA 17  
Manufacturer Address line 2  
Manufacturer's CityGUATEMALA  
Manufacturer Province/StateGT-GU  
Manufacturer Country/AreaGuatemala  
Product Code31ACT03  
FDA Product DescriptionCOFFEE, INSTANT  
Refusal Date07-Jul-2010  
FDA DistrictSWI-DO  
Entry/doc/line/sfx U72-0516383-6/11/1/C
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).