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
Kc Inter-Trde Serice Sdn Bhd Kuala Lumpur , MY NYK-DO U79-0055076-6/4/1B 23CCY05 COCONUT SPREAD (400g) 03-MAR-2008 NUTRIT LBL N.T. Huat Kee Fisheries SDN. BHD. Nibong Tebal MY-07, MY 14300 LOS-DO GL5-0827467-4/1/1 16JGT05 FROZEN RAW HEADLESS SHELL ON BLACK TIGER SHRIMPS 06-MAR-2008 FILTHY N.T. Huat Kee Fisheries SDN. BHD. Nibong Tebal MY-07, MY 14300 LOS-DO GL5-0827467-4/2/1 16JGT05 FROZEN RAW HEADLESS SHELL ON BLACK TIGER SHRIMPS 06-MAR-2008 FILTHY N.T. Huat Kee Fisheries SDN. BHD. Nibong Tebal MY-07, MY 14300 LOS-DO GL5-0827467-4/3/1 16JGT05 FROZEN RAW HEADLESS SHELL ON BLACK TIGER SHRIMPS 06-MAR-2008 FILTHY N.T. Huat Kee Fisheries SDN. BHD. Nibong Tebal MY-07, MY 14300 LOS-DO GL5-0827467-4/4/1 16JGT05 FROZEN RAW HEADLESS SHELL ON BLACK TIGER SHRIMPS 06-MAR-2008 FILTHY N.T. Huat Kee Fisheries SDN. BHD. Nibong Tebal MY-07, MY 14300 LOS-DO GL5-0827467-4/5/1 16JGT05 FROZEN RAW HEADLESS SHELL ON BLACK TIGER SHRIMPS 06-MAR-2008 FILTHY Liwe Trading Selangor D.E. , MY 47300 FLA-DO W69-1321929-2/1/1 80L--YY NON-STERILE LATEX EXAM POWDERED GLOVE 17-MAR-2008 HOLES Beauty Healthy & L Selangor , MY SEA-DO 112-1616332-2/1/1 89N--ZF 861173899591 BHL ION CLEANSE MACHINE 21-MAR-2008 NOT LISTED DIRECTIONS NO 510(K) Goodwell Marketing Kepong , MY SWI-DO AE3-0412171-6/1/1 09CGY15 YOGURT: FLAVOR NATA PUDDING 25-MAR-2008 NEEDS FCE Panasonic Asia Ltd Singapore , SG 199555 FLA-DO 406-0413567-9/1/1 95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY 27-MAR-2008 NON STD Panasonic Asia Ltd Singapore , SG 199555 FLA-DO 406-0413098-5/1/1 95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY 28-MAR-2008 NON STD Panasonic Asia Ltd Singapore , SG 199555 FLA-DO 406-0414315-2/1/1 95R--FV COMPACT AUDIO SYSTEM- FOR EXPORT ONLY 28-MAR-2008 NON STD