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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-0029468-4/3/66


Manufacturer FEI3009185427
Manufacturer NameBukaev.Ru Ltd  
Manufacturer Address line 1Ribinskaya 58  
Manufacturer Address line 2  
Manufacturer's CityNizhniy Novgorod  
Manufacturer Province/State  
Manufacturer Country/AreaRussia  
Product Code53LC03  
FDA Product DescriptionFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)  
Refusal Date11-Jul-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx BQL-0029468-4/3/66
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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