Refusal Actions by FDA as Recorded in OASIS for Sweden

    Manufacturer FEI: 3007111359
    Manufacturer Name: Scyfix
    Manufacturer address line 1: Prospectus Ab Sockenvagen 477
    Manufacturer address line 2:
    Manufacturer's City: Enkede
    Manufacturer Province/state:
    Manufacturer Country: Sweden
    Product code: 77E--TN
    Importers product description: SCYFIX 600
    Refusal date: 19-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-4358825-1/1/1/A
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005553137
    Manufacturer Name: Active Biotech Research
    Manufacturer address line 1: Scheelevagen 22
    Manufacturer address line 2:
    Manufacturer's City: Lund
    Manufacturer Province/state:
    Manufacturer Country: Sweden
    Product code: 56HIE99
    Importers product description: ANTI TUMOR PHARMACEUTICAL - ABR-215050
    Refusal date: 22-SEP-2008
    FDA_District: NYK-DO
    Entry/doc/line/sfx: G76-0092465-6/1/1/
    Carrier: LUFTHANSA CARGO AG
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3005553137
    Manufacturer Name: Active Biotech Research
    Manufacturer address line 1: Scheelevagen 22
    Manufacturer address line 2:
    Manufacturer's City: Lund
    Manufacturer Province/state:
    Manufacturer Country: Sweden
    Product code: 56HIE99
    Importers product description: ANTI TUMOR PHARMACEUTICAL - ABR-215050
    Refusal date: 22-SEP-2008
    FDA_District: NYK-DO
    Entry/doc/line/sfx: G76-0092465-6/1/2/
    Carrier: LUFTHANSA CARGO AG
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3005553137
    Manufacturer Name: Active Biotech Research
    Manufacturer address line 1: Scheelevagen 22
    Manufacturer address line 2:
    Manufacturer's City: Lund
    Manufacturer Province/state:
    Manufacturer Country: Sweden
    Product code: 56HIE99
    Importers product description: ANTI TUMOR PHARMACEUTICAL - ABR-215050
    Refusal date: 22-SEP-2008
    FDA_District: NYK-DO
    Entry/doc/line/sfx: G76-0092465-6/1/3/
    Carrier: LUFTHANSA CARGO AG
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED