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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 BQL-0027174-0/17/2

Manufacturer FEI3008921680
Manufacturer NameLlc Etalon  
Manufacturer Address line 1Ordinka Bolshaya 54str2  
Manufacturer Address line 2  
Manufacturer's CityMoskov  
Manufacturer Province/StateMoskovskaya Obl.  
Manufacturer Country/AreaRussia  
Product Code53IG01  
Importer's Product DescriptionTOOTHPASTE  
Refusal Date02-Mar-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx BQL-0027174-0/17/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.