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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 551-2398712-1/2/1


Manufacturer FEI3003166416
Manufacturer NameFlorence International Llc  
Manufacturer Address line 1If No. 71 Lane 96 Da Shing Street  
Manufacturer Address line 2  
Manufacturer's CityTainan  
Manufacturer Province/State  
Manufacturer Country/AreaTaiwan  
Product Code53CH03  
FDA Product DescriptionEYE SHADOW (EYE MAKEUP PREPARATIONS)  
Refusal Date30-Apr-2013  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 551-2398712-1/2/1
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).  
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
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