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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 112-4000541-6/1/1/D


Manufacturer FEI3007070484
Manufacturer NameLab Natubell  
Manufacturer Address line 1Cra 68h Bis No.34-36 Sur  
Manufacturer Address line 2  
Manufacturer's CityBogaota  
Manufacturer Province/State  
Manufacturer Country/AreaColombia  
Product Code53LC03  
Importer's Product Description862577135079 REDUCING GEL  
Refusal Date27-Dec-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4000541-6/1/1/D
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
UNSAFE COL   402(c), 801(a)(3); ADULTERATION   The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).  
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