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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-0127265-8/3/1/B

Manufacturer FEI3005981004
Manufacturer NameUnknown  
Manufacturer Address line 1Unknown  
Manufacturer Address line 2  
Manufacturer's CityNew York  
Manufacturer Province/StateNY  
Manufacturer Country/AreaUnited States  
Product Code53LC03  
Importer's Product DescriptionEYE MAKE UP KIT  
Refusal Date21-Oct-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx BNW-0127265-8/3/1/B
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).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.