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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 AVB-0925866-2/7/6

Manufacturer FEI3004614585
Manufacturer NameProfrance Eu  
Manufacturer Address line 1Calle 15 No. 68 D 32  
Manufacturer Address line 2  
Manufacturer's CityBogota  
Manufacturer Province/State  
Manufacturer Country/AreaColombia  
Product Code53FY99  
Importer's Product DescriptionANTI HAIR LOSS TREATMENT LOTION X 65 ML  
Refusal Date12-Feb-2013  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AVB-0925866-2/7/6
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).