Refusal Actions by FDA as Recorded in OASIS for Netherlands

    Manufacturer FEI: 3003244806
    Manufacturer Name: Pharmachemie B.V.
    Manufacturer address line 1: P.O.Box 552
    Manufacturer address line 2:
    Manufacturer's City: Haarlem
    Manufacturer Province/state:
    Manufacturer Country: Netherlands
    Product code: 62IIS79
    Importers product description: 671632842098/colfarabine
    Refusal date: 03-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-3901838-8/1/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): DRUG GMPS


    Manufacturer FEI: 3006985584
    Manufacturer Name: Solenne Bv
    Manufacturer address line 1: Zernikepark 12
    Manufacturer address line 2:
    Manufacturer's City: Groningen
    Manufacturer Province/state:
    Manufacturer Country: Netherlands
    Product code: 53YD-99
    Importers product description: 792733625137/SKIN CARE ANTIOXIDANT .25OZ
    Refusal date: 03-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-3881072-8/1/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): COSMETLBLG


    Manufacturer FEI: 3007064350
    Manufacturer Name: Bioclin
    Manufacturer address line 1: Delftechpark 55
    Manufacturer address line 2:
    Manufacturer's City: Delft
    Manufacturer Province/state:
    Manufacturer Country: Netherlands
    Product code: 66VBJ99
    Importers product description: MULTIGYN LIQUIGEL MOISTURIZER
    Refusal date: 11-SEP-2008
    FDA_District: PHI-DO
    Entry/doc/line/sfx: UPS-2013134-6/1/1/
    Carrier: UNITED PARCEL SERVICE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3003969581
    Manufacturer Name: Synthon Bv
    Manufacturer address line 1: Microweg 22
    Manufacturer address line 2:
    Manufacturer's City: Cm Nijmegen
    Manufacturer Province/state:
    Manufacturer Country: Netherlands
    Product code: 63XAB26
    Importers product description: 837359481357  (LEVOCETIRIZINE
    Refusal date: 23-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-2568090-2/1/1/
    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: 3002807888
    Manufacturer Name: Pie Medical Equipment Bv
    Manufacturer address line 1: Philipsweg 1
    Manufacturer address line 2: Po Box 1132
    Manufacturer's City: Maastricht
    Manufacturer Province/state:
    Manufacturer Country: Netherlands
    Product code: 85K--NG
    Importers product description: 856024923442 ULTRASOUND EQUIPMENT
    Refusal date: 23-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-2231093-3/1/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): FAILS STD