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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 BNW-0127265-8/2/1/C

Manufacturer FEI1000274613
Manufacturer NameClinique Laboratories Inc. Dist.  
Manufacturer Address line 1Unknown Street  
Manufacturer Address line 2  
Manufacturer's CityNew York  
Manufacturer Province/StateNY  
Manufacturer Country/AreaUnited States  
Product Code53LC03  
Importer's Product DescriptionSKIN CARE CREAM.  
Refusal Date21-Oct-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx BNW-0127265-8/2/1/C
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.