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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 231-4317256-1/8/3

Manufacturer FEI3009985870
Manufacturer NameBeautiwise Shenzhen Limited  
Manufacturer Address line 1Block No 2/6/8/9 Tung Fu Industrial Dist  
Manufacturer Address line 2Da Peng, Long Gang  
Manufacturer's CityShenzhen  
Manufacturer Province/StateGuandong  
Manufacturer Country/AreaChina  
Product Code53GY10  
Refusal Date15-Jun-2012  
FDA DistrictDET-DO  
Entry/doc/line/sfx 231-4317256-1/8/3
FDA Sample AnalysisYes  
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).  
POISONOUS   601(a), 801(a)(3); ADULTERATION   The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.