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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 918-4653041-7/11/6


Manufacturer FEI3009141025
Manufacturer NameLancome  
Manufacturer Address line 1Unknown Street  
Manufacturer Address line 2  
Manufacturer's CityTroyes Cedex  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LC03  
FDA Product DescriptionFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)  
Refusal Date28-Oct-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 918-4653041-7/11/6
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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