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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 112-6264623-9/1/1

Manufacturer FEI3003221709
Manufacturer NameAtrium Innovations Inc.  
Manufacturer Address line 11405 Boul Du Parc Technologique  
Manufacturer Address line 2  
Manufacturer's CityQuebec  
Manufacturer Province/StateQuebec  
Manufacturer Country/AreaCanada  
Product Code53PD99  
Importer's Product Description674898537353 TYROSTAT LIQUID COSMETIC INGREDIENT  
Refusal Date07-Jan-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-6264623-9/1/1
FDA Sample AnalysisNo  
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.