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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 940-0175354-3/1/67


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 Code53LC03  
Importer's Product DescriptionHAND CREAM  
Refusal Date27-Jan-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 940-0175354-3/1/67
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
LACKS FIRM   502(b)(1), 801(a)(3); MISBRANDING   The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.  
LACKS N/C   502(b)(2), 801(a)(3); MISBRANDING   The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.  
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. 201.15(c)(1).  
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