Refusal Actions by FDA as Recorded in OASIS for Australia

    Manufacturer FEI: 3004558396
    Manufacturer Name: Cat Media
    Manufacturer address line 1: Lil 13, 309 Kent St
    Manufacturer address line 2:
    Manufacturer's City: Sydney
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 53LC-06
    Importers product description: GAMMA HYDROXY 50 ML
    Refusal date: 07-OCT-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: 820-0574895-7/4/1/
    Carrier: UNITED AIR LINES,INC.
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3004558396
    Manufacturer Name: Cat Media
    Manufacturer address line 1: Lil 13, 309 Kent St
    Manufacturer address line 2:
    Manufacturer's City: Sydney
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 53LC-06
    Importers product description: POTENT C TRIPLE SERUM 30 ML
    Refusal date: 07-OCT-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: 820-0574895-7/4/4/
    Carrier: UNITED AIR LINES,INC.
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3004558396
    Manufacturer Name: Cat Media
    Manufacturer address line 1: Lil 13, 309 Kent St
    Manufacturer address line 2:
    Manufacturer's City: Sydney
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 53LC-08
    Importers product description: ZIT ZAPPER 10 ML
    Refusal date: 07-OCT-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: 820-0574895-7/4/8/
    Carrier: UNITED AIR LINES,INC.
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3004558396
    Manufacturer Name: Cat Media
    Manufacturer address line 1: Lil 13, 309 Kent St
    Manufacturer address line 2:
    Manufacturer's City: Sydney
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 53LC-10
    Importers product description: RAPID PEEL 30 ML
    Refusal date: 07-OCT-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: 820-0574895-7/4/10/
    Carrier: UNITED AIR LINES,INC.
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3004558396
    Manufacturer Name: Cat Media
    Manufacturer address line 1: Lil 13, 309 Kent St
    Manufacturer address line 2:
    Manufacturer's City: Sydney
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 53LC-03
    Importers product description: VEIN AWAY PLUS 100 ML
    Refusal date: 07-OCT-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: 820-0574895-7/4/12/
    Carrier: UNITED AIR LINES,INC.
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3007138358
    Manufacturer Name: Colgate Pamolive Pty
    Manufacturer address line 1: 14/345 George St
    Manufacturer address line 2:
    Manufacturer's City: Sydney
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 61LIJ14
    Importers product description: CHLOROFLUOR TOPICAL GEL
    Refusal date: 07-OCT-2008
    FDA_District: NYK-DO
    Entry/doc/line/sfx: AEK-9137227-2/1/1/
    Carrier: QANTAS AIRWAYS LIMITED
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3003620101
    Manufacturer Name: Alpha Pty
    Manufacturer address line 1: 15
    Manufacturer address line 2:
    Manufacturer's City: Car
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 60MIS24
    Importers product description: 704821263336/DUROGESIC PATCHES
    Refusal date: 10-OCT-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-4604508-5/1/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED
               NOT LISTED


    Manufacturer FEI: 3006474343
    Manufacturer Name: Boston Scientific
    Manufacturer address line 1: 247 Coward St
    Manufacturer address line 2:
    Manufacturer's City: Sydney
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 74D--XY
    Importers product description: DEFIBRILLATOR-FOR DISPOSAL
    Refusal date: 14-OCT-2008
    FDA_District: LOS-DO
    Entry/doc/line/sfx: AEK-9686833-2/1/2/
    Carrier: QANTAS AIRWAYS LIMITED
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO PMA


    Manufacturer FEI: 3006474343
    Manufacturer Name: Boston Scientific
    Manufacturer address line 1: 247 Coward St
    Manufacturer address line 2:
    Manufacturer's City: Sydney
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 74L--WO
    Importers product description: DEFIBRILLATOR-RETURN FOR WARRANTY
    Refusal date: 14-OCT-2008
    FDA_District: LOS-DO
    Entry/doc/line/sfx: AEK-9686833-2/1/3/
    Carrier: QANTAS AIRWAYS LIMITED
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO PMA


    Manufacturer FEI: 3006474343
    Manufacturer Name: Boston Scientific
    Manufacturer address line 1: 247 Coward St
    Manufacturer address line 2:
    Manufacturer's City: Sydney
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 74N--IK
    Importers product description: DEFIBRILLATOR- RETURN FOR WARRANTY
    Refusal date: 14-OCT-2008
    FDA_District: LOS-DO
    Entry/doc/line/sfx: AEK-9686833-2/1/6/
    Carrier: QANTAS AIRWAYS LIMITED
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO PMA
               REGISTERED


    Manufacturer FEI: 3006474343
    Manufacturer Name: Boston Scientific
    Manufacturer address line 1: 247 Coward St
    Manufacturer address line 2:
    Manufacturer's City: Sydney
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 74L--WP
    Importers product description: DEFIBRILLATOR- RETURN FOR DISPOSAL
    Refusal date: 14-OCT-2008
    FDA_District: LOS-DO
    Entry/doc/line/sfx: AEK-9686833-2/1/7/
    Carrier: QANTAS AIRWAYS LIMITED
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO PMA
               REGISTERED


    Manufacturer FEI: 3006779650
    Manufacturer Name: Blooms Health Products
    Manufacturer address line 1: 1/10 Morgan Street
    Manufacturer address line 2:
    Manufacturer's City: Botanybotany
    Manufacturer Province/state:
    Manufacturer Country: Australia
    Product code: 54YEY99
    Importers product description: Slippery Elm Bark Powder
    Refusal date: 31-OCT-2008
    FDA_District: LOS-DO
    Entry/doc/line/sfx: AEK-9690291-7/1/1/
    Carrier: QANTAS AIRWAYS LIMITED
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED