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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 940-0175354-3/1/39

Manufacturer FEI3008045057
Manufacturer NameBest-pharm Ltd.  
Manufacturer Address line 124/12 B. Koretnei Per.  
Manufacturer Address line 2Side 1  
Manufacturer's CityMoscow  
Manufacturer Province/StateRU-MOW  
Manufacturer Country/AreaRussia  
Product Code53LA99  
Importer's Product DescriptionSKIN CREAM  
Refusal Date07-Mar-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 940-0175354-3/1/39
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.  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.