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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 224-1157000-9/3/1

Manufacturer FEI3007955503
Manufacturer NameWolfe Brothers  
Manufacturer Address line 1No 7 Te-Hsing 6th Rd, Su-Ao I-Lan  
Manufacturer Address line 2  
Manufacturer's CityYilan  
Manufacturer Province/State  
Manufacturer Country/AreaTaiwan  
Product Code53GG10  
Refusal Date04-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 224-1157000-9/3/1
FDA Sample AnalysisYes  
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).