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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-2121943-2/7/1

Manufacturer FEI3008369878
Manufacturer NameAir Transatcara Flight Operations  
Manufacturer Address line 13551 Jericho Rd  
Manufacturer Address line 2  
Manufacturer's CityRichmond  
Manufacturer Province/StateBRITISH COLUMBIA  
Manufacturer Country/AreaCanada  
Product Code53GK05  
Importer's Product DescriptionLIP STICK MAKEUPS.  
Refusal Date01-Feb-2013  
FDA DistrictFLA-DO  
Entry/doc/line/sfx BNW-2121943-2/7/1
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.