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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 N77-0163714-2/6/1

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 Code53JY01  
Refusal Date05-May-2010  
FDA DistrictNYK-DO  
Entry/doc/line/sfx N77-0163714-2/6/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).  
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.