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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 UPS-8577442-6/3/1/B

Manufacturer FEI3006592915
Manufacturer NameLa Biosthetique  
Manufacturer Address line 13-5 Guelichstrasse  
Manufacturer Address line 2  
Manufacturer's CityPforzheimpforzheim  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53LD01  
Importer's Product DescriptionVISALIX PURIFANT  
Refusal Date23-Jan-2013  
FDA DistrictNYK-DO  
Entry/doc/line/sfx UPS-8577442-6/3/1/B
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
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.