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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 N77-0163714-2/7/1

Manufacturer FEI3007776717
Manufacturer NameEkzon  
Manufacturer Address line 1Str. Lenina, 202,  
Manufacturer Address line 2  
Manufacturer's CityDrogichin  
Manufacturer Province/StateBY-BR  
Manufacturer Country/AreaBelarus  
Product Code54ABY13  
FDA Product DescriptionVITAMIN C (ASCORBIC ACID)  
Refusal Date05-May-2010  
FDA DistrictNYK-DO  
Entry/doc/line/sfx N77-0163714-2/7/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO ENGLISH   502(c); 801(a)(3);Misbranding   Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)