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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 AF4-0581272-4/2/1

Manufacturer FEI3005760485
Manufacturer NameYiwu City Ludanmei Cosmetics Co. Ltd.  
Manufacturer Address line 1No. 15 North Road, Wuyan  
Manufacturer Address line 2Yidong Niansanli Industrial Zone  
Manufacturer's CityYiwu City, Yiwu City, Jinhua, Zhejiang  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code53CF03  
Refusal Date12-Mar-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx AF4-0581272-4/2/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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.  
HELD INSAN   601(c), 801(a)(3); ADULTERATION   The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.