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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 UPS-9506350-5/1/1

Manufacturer FEI3010007757
Manufacturer Nameareum dawoon Cosmetics  
Manufacturer Address line 1361-12 Bun-Gi  
Manufacturer Address line 2  
Manufacturer's CityChungnam  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53FY99  
Importer's Product DescriptionHAIR CARE SYSTEM  
Refusal Date28-Feb-2013  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-9506350-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
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).