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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 551-9758875-4/1/8

Manufacturer FEI3003620149
Manufacturer NameCosmetiques France Laure  
Manufacturer Address line 111970 Albert Hudon  
Manufacturer Address line 2  
Manufacturer's CityMontreal-Nord  
Manufacturer Province/StateQC  
Manufacturer Country/AreaCanada  
Product Code53LD03  
Importer's Product DescriptionDEPIL ANTISEPTIC PRE  
Refusal Date13-Dec-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 551-9758875-4/1/8
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
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.