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