Refusal Actions by FDA as Recorded in OASIS for Malaysia

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Panasonic Latin America S A Colon , PA FLA-DO BJM-0110606-3/1/1 95L--32 COMPACT AUDIO SYSTEM SC-AK250GCPS 05-NOV-2007 NON STD Panasonic Latin America S A Colon , PA FLA-DO BJM-0110606-3/1/2 95L--32 COMPACT AUDIO SYSTEM SC-AK350GCPS 05-NOV-2007 NON STD Panasonic Latin America S A Colon , PA FLA-DO BJM-0110606-3/1/3 95L--32 COMPACT AUDIO SYSTEM SC-AK750GCPK 05-NOV-2007 NON STD Panasonic Latin America S A Colon , PA FLA-DO BJM-0110606-3/1/4 95L--32 COMPACT AUDIO SYSTEM SC-AK450GCPK 05-NOV-2007 NON STD Panasonic Latin America S A Colon , PA FLA-DO BJM-0110606-3/1/5 95L--32 COMPACT AUDIO SYSTEM SC-AK860GCPK 05-NOV-2007 NON STD Panasonic Asia Ltd Singapore , SG 199555 FLA-DO 406-0406849-0/1/1 95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY 06-NOV-2007 NON STD Panasonic Asia Ltd Singapore , SG 199555 FLA-DO 406-0406855-7/1/1 95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY 06-NOV-2007 NON STD Sony Corporation Penang , MY FLA-DO TW2-0011699-8/1/1 95L--31 AUDIO SYSTEMS / FOR EXPORT ONLY / EXPORT ONLY 06-NOV-2007 NON STD Panasonic Asia Ltd Singapore , SG 199555 FLA-DO 406-0407061-1/1/1 95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY 08-NOV-2007 NON STD Panasonic Asia Ltd Singapore , SG 199555 FLA-DO 406-0407063-7/1/1 95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY 08-NOV-2007 NON STD Sony Corporation Penang , MY FLA-DO TW2-0011736-8/1/1 95L--31 AUDIO SYSTEMS / FOR EXPORT ONLY 08-NOV-2007 NON STD Sony Corporation Penang , MY FLA-DO TW2-0011736-8/2/1 95L--31 AUDIO SYSTEMS / FOR EXPORT ONLY 08-NOV-2007 NON STD Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0297284-3/2/1 16JGD05 FRZ. RAW SHELL ON HEADLESS SHELL ON PINK SHRIMP 16/20 13-NOV-2007 SALMONELLA Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0297284-3/3/1 16XGD21 FRZ. RAW SHELL ON PINK AND WHITE SHRIMP 21/25 13-NOV-2007 SALMONELLA Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0297284-3/5/1 16XGD21 31/40 Headless Shell On White Shrimp 13-NOV-2007 SALMONELLA Panasonic Asia Ltd Singapore , SG 199555 FLA-DO 406-0407113-0/1/1 95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY 14-NOV-2007 NON STD Panasonic Asia Ltd Singapore , SG 199555 FLA-DO 406-0407362-3/1/1 95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY 16-NOV-2007 NON STD Panasonic Asia Ltd Singapore , SG 199555 FLA-DO 406-0407298-9/1/1 95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY 19-NOV-2007 NO REGISTR Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0298448-3/3/2 16JGD05 FRZ. RAW SHELL ON PINK SHRIMP 21/25 21-NOV-2007 SALMONELLA Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0298448-3/2/3 16JGD05 FRZ. RAW SHELL ON PINK SHRIMP 16/20 21-NOV-2007 SALMONELLA Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0297949-1/3/1 16JGD05 FR EZ PEEL PINK SHRIMP 21/25 21-NOV-2007 SALMONELLA Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0297949-1/4/1 16JGD05 FRZ RAW EZ PEEL PINK SHRIMP 21-NOV-2007 SALMONELLA Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0297949-1/5/1 16JGD05 FRZ. RAW EZ PEEL PINK SHRIMP 41/50 21-NOV-2007 SALMONELLA Sony Corporation Penang , MY FLA-DO TW2-0011802-8/1/1 95L--31 AUDIO SYSTEMS / FOR EXPORT ONLY 26-NOV-2007 NON STD Sony Corporation Penang , MY FLA-DO TW2-0011802-8/2/1 95L--31 AUDIO SYSTEMS / FOR EXPORT ONLY 26-NOV-2007 NON STD Sony Corporation Penang , MY FLA-DO TW2-0011802-8/3/1 95L--31 AUDIO SYSTEMS / FOR EXPORT ONLY 26-NOV-2007 NON STD Goodwell Marketing Kepong , MY LOS-DO GX1-0836247-4/1/3 03YGT99 FORTUNE YOGURT FLV NATA PUDDING 26-NOV-2007 NEEDS FCE NO PROCESS Panasonic Trading Malaysia Johor Bahru , MY FLA-DO BJM-0110705-3/1/1 95L--32 COMPACT AUDIO SYSTEM SC-AK350GCPS (EXPORT ONLY) 30-NOV-2007 NON STD Panasonic Trading Malaysia Johor Bahru , MY FLA-DO BJM-0110705-3/1/2 95L--32 COMPACT AUDIO SYSTEM SC-AK450GCPK (EXPORT ONLY) 30-NOV-2007 NON STD Panasonic Trading Malaysia Johor Bahru , MY FLA-DO BJM-0110705-3/1/3 95L--32 COMPACT AUDIO SYSTEM SC-AK750GCPK (EXPORT ONLY) 30-NOV-2007 NON STD Panasonic Trading Malaysia Johor Bahru , MY FLA-DO BJM-0110705-3/1/4 95L--32 COMPACT AUDIO SYSTEM SC-AK250GCPS (EXPORT ONLY) 30-NOV-2007 NON STD