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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-0162290-5/1/2

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 Code53LD03  
Importer's Product DescriptionPHOTO AGE REVERSE SERUM  
Refusal Date04-Jan-2013  
FDA DistrictNYK-DO  
Entry/doc/line/sfx OHL-0162290-5/1/2
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.