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 Asia Ltd Singapore , SG 199555 FLA-DO 406-0418480-0/1/1 95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY 04-AUG-2008 NON STD Yeo Hiap Seng (Malaysia) Berhad Petaling Jaya MY-10, MY 46050 SWI-DO 805-0119075-7/1/1 29AGE99 SOY MILK 04-AUG-2008 NO PROCESS Lian Hoc Food Manufacturing Sdn Bhd Masai Johor , MY LOS-DO AJR-2913317-8/2/1 16AGT45 FROZEN TUNA SAKU 06-AUG-2008 HISTAMINE FILTHY Lian Hoc Food Manufacturing Sdn Bhd Masai Johor , MY LOS-DO AJR-2913317-8/2/3 16AGT45 FROZEN TUNA GROUND MEAT 06-AUG-2008 HISTAMINE FILTHY Lian Hoc Food Manufacturing Sdn Bhd Masai Johor , MY LOS-DO AJR-2913317-8/2/4 16AGT45 FROZEN TUNA CUBE 06-AUG-2008 HISTAMINE FILTHY Lian Hoc Food Manufacturing Sdn Bhd Masai Johor , MY LOS-DO AJR-2913317-8/2/5 16AGT45 FROZEN TUNA STEAK 06-AUG-2008 HISTAMINE FILTHY Lian Hoc Food Manufacturing Sdn Bhd Masai Johor , MY LOS-DO AJR-2913317-8/2/6 16AGT45 FROTUNA LOIN 06-AUG-2008 HISTAMINE FILTHY Lian Hoc Food Manufacturing Sdn Bhd Masai Johor , MY LOS-DO AJR-2913317-8/2/2 16AGT45 FROZEN TUNA STRIP MEAT 06-AUG-2008 HISTAMINE FILTHY Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0302569-0/1/4 16JGD05 FRZ. RAW HEADLESS SHELL ON WHITE SHRIMP SIZE 8/12 11-AUG-2008 SALMONELLA Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0302569-0/1/5 16JGD05 FRZ. RAW HEADLESS SHELL ON WHITES SHRIMP SIZE 13/15 11-AUG-2008 SALMONELLA Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0302569-0/2/2 16JGD05 FRZ. RAW HEADLESS SHELL ON WHITES SHRIMP SIZE 16/20 11-AUG-2008 SALMONELLA Minobe Swissan (M) Sdn Bhd Mersing, , MY 86800 LOS-DO 082-0302569-0/4/1 16JGD05 FRZ. RAW HEADLESS SHELL ON WHITES SHRIMP SIZE 21/25 11-AUG-2008 SALMONELLA Panasonic Asia Ltd Singapore , SG 199555 FLA-DO 406-0419692-9/1/1 95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY 25-AUG-2008 NON STD Thomyam Food Industries Sdn.Bhd.(Pvt.Ltd) Kuantan MY-C, MY 25350 SAN-DO D52-0928120-8/2/4 35DHT99 MANGO MINI PUDDING 27-AUG-2008 INCONSPICU Thomyam Food Industries Sdn.Bhd.(Pvt.Ltd) Kuantan MY-C, MY 25350 SAN-DO D52-0928120-8/2/1 35DHT99 MANGO PUDDING 27-AUG-2008 INCONSPICU Supermax Gloves Sungai , MY 47000 FLA-DO BIP-0013426-4/2/1 80L--YY NEW ENGLAND EXAM GLOVES LG- POWDER FREE- NOT FOR RESALE-FOR 28-AUG-2008 REGISTERED Supermax Gloves Sungai , MY 47000 FLA-DO BIP-0013426-4/2/2 80L--YY NEW ENGLAND EXAM GLOVES LATEX POWDER- NOT FOR RESALE-FOR EXH 28-AUG-2008 REGISTERED Supermax Gloves Sungai , MY 47000 FLA-DO BIP-0013426-4/2/3 80L--YY NEW ENGLAND EXAM GLOVES LATEX LG POWDER FREE-NOT FOR RESALE- 28-AUG-2008 REGISTERED Maytech Life Industries Johor , MY 84700 FLA-DO 660-0491065-0/3/2 66PBU99 SUNSCREEN - NO NDC NUMBER - WAREHOUSE ENTRY FILED 29-AUG-2008 NOT LISTED