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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 AMS-0002890-1/9/1

Manufacturer FEI3008991731
Manufacturer NameLancome Parf. & Beaute Cie  
Manufacturer Address line 1Avenue Henri Lefebvre B.P.189  
Manufacturer Address line 2  
Manufacturer's CityCaudry  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LC99  
Importer's Product DescriptionL1372100 GENIFIQ SOL BODY SPF15 B150M  
Refusal Date22-Jan-2013  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AMS-0002890-1/9/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).