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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 MC2-6348733-2/1/1

Manufacturer FEI1000572066
Manufacturer NameShiseido International France S.A.S.  
Manufacturer Address line 1La Fontaine Challoy  
Manufacturer Address line 2  
Manufacturer's CityAutry Le Chatel  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LD03  
Importer's Product DescriptionLOTIONS  
Refusal Date13-Nov-2012  
FDA DistrictPHI-DO  
Entry/doc/line/sfx MC2-6348733-2/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.