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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 EUV-0001550-5/4/2


Manufacturer FEI3002716777
Manufacturer NameLaboratorios del Sur, C. por A.  
Manufacturer Address line 1Unknown  
Manufacturer Address line 2  
Manufacturer's CitySanto Domingo  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code53ED99  
FDA Product DescriptionOTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.  
Refusal Date21-Dec-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx EUV-0001550-5/4/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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