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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 484-2025526-6/5/1/C


Manufacturer FEI3009625181
Manufacturer NameBlue Heaven Cosmetics Pvt. Ltd. (Unit - II)  
Manufacturer Address line 1C-158 Naraina Indl. Area Phase-I  
Manufacturer Address line 2  
Manufacturer's CityNew Delhi  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53CK02  
FDA Product DescriptionEYELINER (EYE MAKEUP PREPARATIONS)  
Refusal Date05-Mar-2013  
FDA DistrictCHI-DO  
Entry/doc/line/sfx 484-2025526-6/5/1/C
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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