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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 N77-0163714-2/3/5

Manufacturer FEI3006185515
Manufacturer NameCjsc Vitex  
Manufacturer Address line 12 Smirnov Str Minsk  
Manufacturer Address line 2  
Manufacturer's CityBelarus  
Manufacturer Province/State  
Manufacturer Country/AreaBelarus  
Product Code53LC06  
Importer's Product DescriptionNIGHT CREAM FOR NORMAL SKIN  
Refusal Date05-May-2010  
FDA DistrictNYK-DO  
Entry/doc/line/sfx N77-0163714-2/3/5
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(A); 801(a)(3) Misbranding   It appears the label does not bear the common or usual name of the cosmetic.  
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
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