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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 BZG-0001999-4/1/1

Manufacturer FEI3009093361
Manufacturer NameLaboratorios Demac Ltda  
Manufacturer Address line 1Cr 81b 8137  
Manufacturer Address line 2  
Manufacturer's CityBogota  
Manufacturer Province/State  
Manufacturer Country/AreaColombia  
Product Code53LY99  
Importer's Product DescriptionBODY SCULPTING GEL  
Refusal Date20-Oct-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BZG-0001999-4/1/1
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).  
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