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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 112-2271413-6/1/3

Manufacturer FEI3003818446
Manufacturer NameLa Roche-Posay Laboratories Pharmaceutique (L.R.P)  
Manufacturer Address line 1Avenue Rene Lavayer  
Manufacturer Address line 2  
Manufacturer's CityLa Roche Posay  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LC99  
Importer's Product Description794705174590 SKIN CREAM  
Refusal Date28-Dec-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-2271413-6/1/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(A); 801(a)(3) Misbranding   It appears the label does not bear the common or usual name of the cosmetic.