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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 OHL-0090137-5/1/7

Manufacturer FEI3007821703
Manufacturer NameCat Media Pty Limited  
Manufacturer Address line 118 Jubilee Ave  
Manufacturer Address line 2  
Manufacturer's CityWarriewood  
Manufacturer Province/StateNew South Wales  
Manufacturer Country/AreaAustralia  
Product Code53LC06  
Refusal Date23-Jan-2012  
FDA DistrictCHI-DO  
Entry/doc/line/sfx OHL-0090137-5/1/7
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
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.