Refusal Actions by FDA as Recorded in OASIS for Malaysia


    Manufacturer FEI: 3006693277
    Manufacturer Name: Etumax Corporation Sdn Bhd
    Manufacturer address line 1: No. 102, Jalan Gasing Seksyen 5,
    Manufacturer address line 2: Petaling Jaya 46000
    Manufacturer's City: Selangor
    Manufacturer Province/state: My-10
    Manufacturer Country: Malaysia
    Product code: 54FCH47
    Importers product description: PHYTO SHAPE WEIGHT LOSS SUPPLEMENT
    Refusal date: 02-MAY-2008
    FDA_District: NYK-DO
    Entry/doc/line/sfx: UPS-0223523-0/1/1/
    Carrier: UNITED PARCEL SERVICE OF CANA
    Bill of Lading:
    FDA sample analysis: Yes
    FDA record of private lab sample analysis: No
    Charge(s): UNSFDIETLB


    Manufacturer FEI: 3004102673
    Manufacturer Name: Sony Corporation
    Manufacturer address line 1: Prai Industrial Estate 13600 Prai
    Manufacturer address line 2:
    Manufacturer's City: Penang
    Manufacturer Province/state:
    Manufacturer Country: Malaysia
    Product code: 95L--31
    Importers product description: AUDIO SYSTEMS / FOR EXPORT ONLY
    Refusal date: 06-MAY-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: TW2-0012406-7/1/1/
    Carrier: APL CO PTE LTD-NOL GROUP
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NO REGISTR


    Manufacturer FEI: 3004102673
    Manufacturer Name: Sony Corporation
    Manufacturer address line 1: Prai Industrial Estate 13600 Prai
    Manufacturer address line 2:
    Manufacturer's City: Penang
    Manufacturer Province/state:
    Manufacturer Country: Malaysia
    Product code: 95L--31
    Importers product description: AUDIO SYSTEMS / FOR EXPORT ONLY
    Refusal date: 06-MAY-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: TW2-0012407-5/1/1/
    Carrier: CROWLEY LINER SERVICES INC
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NO REGISTR


    Manufacturer FEI: 3003449565
    Manufacturer Name: Apollo Food Industries ( Sdn Bhd
    Manufacturer address line 1: No 70 Jalan Langkasuka, Larkin Ind Area
    Manufacturer address line 2:
    Manufacturer's City: Johor
    Manufacturer Province/state:
    Manufacturer Country: Malaysia
    Product code: 33LGT06
    Importers product description: GUMMY CANDY
    Refusal date: 06-MAY-2008
    FDA_District: LOS-DO
    Entry/doc/line/sfx: 610-2830282-8/1/1/
    Carrier: YANG MING MARINE TRANSPORT CO
    Bill of Lading: LUW301043817
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNSAFE COL
               DISEASED


    Manufacturer FEI: 3006306927
    Manufacturer Name: Danone Snacks Manufacturing
    Manufacturer address line 1: 2638 Jalan Perusahaan,Kawasan
    Manufacturer address line 2:
    Manufacturer's City: Perai Pulau Pinang, Mal
    Manufacturer Province/state:
    Manufacturer Country: Malaysia
    Product code: 07BGT06
    Importers product description: Potato chips- curry bbq
    Refusal date: 13-MAY-2008
    FDA_District: LOS-DO
    Entry/doc/line/sfx: JN4-0055114-7/5/22/
    Carrier: HYUNDAI MERCHANT MARINE
    Bill of Lading: HKCA9631138
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): LIST INGRE


    Manufacturer FEI: 3004524994
    Manufacturer Name: Dahfa Foods Manufacturing Sdn Bhd
    Manufacturer address line 1: Lot 1283 & 1284 Jalan Perbadanan
    Manufacturer address line 2: Pending Ind. Estate Bintawa
    Manufacturer's City: Kuching
    Manufacturer Province/state: Sarawak
    Manufacturer Country: Malaysia
    Product code: 16SGT12
    Importers product description: Sesame Cod Fish Fillet
    Refusal date: 23-MAY-2008
    FDA_District: CHI-DO
    Entry/doc/line/sfx: G83-9602148-3/2/1/B
    Carrier: HYUNDAI MERCHANT MARINE
    Bill of Lading: HDMUHKWB9626
    FDA sample analysis: Yes
    FDA record of private lab sample analysis: No
    Charge(s): LIST INGRE
               LACKS FIRM
               LACKS N/C
               USUAL NAME
               NUTRIT LBL


    Manufacturer FEI: 3004102673
    Manufacturer Name: Sony Corporation
    Manufacturer address line 1: Prai Industrial Estate 13600 Prai
    Manufacturer address line 2:
    Manufacturer's City: Penang
    Manufacturer Province/state:
    Manufacturer Country: Malaysia
    Product code: 95L--31
    Importers product description: MINI HI FI COMPONENTS / FOR EXPORT ONLY
    Refusal date: 23-MAY-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: TW2-0012471-1/1/1/
    Carrier: APL CO PTE LTD-NOL GROUP
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NON STD


    Manufacturer FEI: 3003757231
    Manufacturer Name: Plexus Manufacturing Sdn Bhd
    Manufacturer address line 1: Bayan Lepas Free Industrial Zonephase Ii
    Manufacturer address line 2:
    Manufacturer's City: Penang
    Manufacturer Province/state:
    Manufacturer Country: Malaysia
    Product code: 74N--VZ
    Importers product description: CARELINK MONITOR FOR CANADA (IFE)
    Refusal date: 29-MAY-2008
    FDA_District: CHI-DO
    Entry/doc/line/sfx: 004-5011564-7/1/1/
    Carrier: EVA AIRWAYS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3003757231
    Manufacturer Name: Plexus Manufacturing Sdn Bhd
    Manufacturer address line 1: Bayan Lepas Free Industrial Zonephase Ii
    Manufacturer address line 2:
    Manufacturer's City: Penang
    Manufacturer Province/state:
    Manufacturer Country: Malaysia
    Product code: 74N--VZ
    Importers product description: CARELINK MONITOR FOR CANADA (IFE)
    Refusal date: 29-MAY-2008
    FDA_District: CHI-DO
    Entry/doc/line/sfx: 004-5011517-5/1/1/
    Carrier: EVA AIRWAYS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3003757231
    Manufacturer Name: Plexus Manufacturing Sdn Bhd
    Manufacturer address line 1: Bayan Lepas Free Industrial Zonephase Ii
    Manufacturer address line 2:
    Manufacturer's City: Penang
    Manufacturer Province/state:
    Manufacturer Country: Malaysia
    Product code: 74D--XY
    Importers product description: CARELINK MONITOR FOR CANADA
    Refusal date: 29-MAY-2008
    FDA_District: CHI-DO
    Entry/doc/line/sfx: 004-5011517-5/2/1/
    Carrier: EVA AIRWAYS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3003757231
    Manufacturer Name: Plexus Manufacturing Sdn Bhd
    Manufacturer address line 1: Bayan Lepas Free Industrial Zonephase Ii
    Manufacturer address line 2:
    Manufacturer's City: Penang
    Manufacturer Province/state:
    Manufacturer Country: Malaysia
    Product code: 74N--VZ
    Importers product description: MODEL 2490C0022K CARELINK MONITOR
    Refusal date: 29-MAY-2008
    FDA_District: CHI-DO
    Entry/doc/line/sfx: 004-5011251-1/1/1/
    Carrier: EVA AIRWAYS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED