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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 M21-0744959-9/4/1

Manufacturer FEI3006362944
Manufacturer NameLaboratorio De Cosmeticos Zande  
Manufacturer Address line 1Cl 42 4369  
Manufacturer Address line 2  
Manufacturer's CityBarranquilla  
Manufacturer Province/State  
Manufacturer Country/AreaColombia  
Product Code53EC07  
Importer's Product DescriptionCAPILAR MASSAGE 550GR ALOE  
Refusal Date13-Jun-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx M21-0744959-9/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).