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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 551-9758875-4/13/2


Manufacturer FEI3008815370
Manufacturer NameLaboratoire Pharma-Cosmetiques  
Manufacturer Address line 12864 Boul Industriel  
Manufacturer Address line 2  
Manufacturer's CityLaval  
Manufacturer Province/StateQC  
Manufacturer Country/AreaCanada  
Product Code53LY02  
Importer's Product DescriptionCREME DE LA CREME LUKEWARM  
Refusal Date13-Dec-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 551-9758875-4/13/2
FDA Sample AnalysisYes  
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.  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
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