Refusal Actions by FDA as Recorded in OASIS for Indonesia
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 406-0419373-6/2/1
95R--FW DVD PLAYER - FOR EXPORT ONLY
04-AUG-2008 NON STD
Tunggal Jaya Prima
Medan ID-SU, ID 20362 LOS-DO 442-0163096-7/6/1
36BCT99 MARQUISA SYRUP SARANG TAWON
04-AUG-2008 UNSAFE COL
Tunggal Jaya Prima
Medan ID-SU, ID 20362 LOS-DO 442-0159265-4/3/1
36BCT99 SYRUP MARQUISA SARANG TAWON
04-AUG-2008 UNSAFE COL
PT. MAKMUR JAYA SEJAHTERA
DENPASAR ID-BA, ID 80361 LOS-DO 224-4307727-0/1/1
16AGD45 FROZEN TUNA SAKU YF 2BG X11LB
11-AUG-2008 FILTHY
PT. MAKMUR JAYA SEJAHTERA
DENPASAR ID-BA, ID 80361 LOS-DO 224-4307727-0/1/2
16AGD45 FROZEN TUNA SAKU BE 2BG X11LB
11-AUG-2008 FILTHY
PT. MAKMUR JAYA SEJAHTERA
DENPASAR ID-BA, ID 80361 LOS-DO 224-4307727-0/1/3
16AGD45 FROZEN TUNA SAKU BF 2BG X11LB
11-AUG-2008 FILTHY
PT. MAKMUR JAYA SEJAHTERA
DENPASAR ID-BA, ID 80361 LOS-DO 224-4307727-0/1/4
16AGD45 FROZEN SOUTHERN BLUE FIN TUNA 2BG X11LB
11-AUG-2008 FILTHY
PT. MAKMUR JAYA SEJAHTERA
DENPASAR ID-BA, ID 80361 LOS-DO 224-4307727-0/1/5
16AGD45 FROZEN SOUTHERN BLUE FIN TUNA 2BG X11LB
11-AUG-2008 FILTHY
PT. MAKMUR JAYA SEJAHTERA
DENPASAR ID-BA, ID 80361 LOS-DO 224-4307727-0/1/6
16AGD45 FROZEN TUNA CUBE 2BG X11LB
11-AUG-2008 FILTHY
PT. MAKMUR JAYA SEJAHTERA
DENPASAR ID-BA, ID 80361 LOS-DO 224-4307727-0/1/7
16AGD45 FROZEN TUNA STRIP MEAT 2BG X11LB
11-AUG-2008 FILTHY
Hudora Utama, Pt.
Jakarta , ID LOS-DO 082-0303198-7/2/1
16MGD09 IQF WHOLE FROZEN CLEANED OCTOPUS 4/6,6/8 LBS
11-AUG-2008 FILTHY
Nippon Meat Packers Singapore Pte Ltd
Singapore , SG LOS-DO AQZ-0264301-6/1/6
16AVT45 FROZEN TUNA PRODUCTS, CUBE MEAT - (152CTNS)
12-AUG-2008 SALMONELLA
Nippon Meat Packers Singapore Pte Ltd
Singapore , SG LOS-DO AQZ-0264301-6/1/7
16AVT45 FROZEN TUNA PRODUCTS, GROUND MEAT - (608CTNS)
12-AUG-2008 SALMONELLA
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 FLA-DO 605-4058683-5/1/1
16SVT45 FROZEN TUNA PIECES
15-AUG-2008 SALMONELLA
Pt Yupi Indo Jelly Gum
Bogor , ID SEA-DO MK8-0393270-8/1/1
33LGT06 BEARS - GUMMI CONFECTIONARY
19-AUG-2008 UNSAFE COL
Pt Yupi Indo Jelly Gum
Bogor , ID SEA-DO MK8-0393270-8/2/1
33LGT06 WORM - GUMMI CONFECTIONARY
19-AUG-2008 UNSAFE COL
Pt Yupi Indo Jelly Gum
Bogor , ID SEA-DO MK8-0393270-8/3/1
33LGT06 SOUR WORMS - GUMMI CONFECTIONARY
19-AUG-2008 UNSAFE COL
Pt Yupi Indo Jelly Gum
Bogor , ID SEA-DO MK8-0393270-8/4/1
33LGT06 PEACH RINGS - GUMMI CONFECTIONARY
19-AUG-2008 UNSAFE COL
Pt Yupi Indo Jelly Gum
Bogor , ID SEA-DO MK8-0393270-8/6/1
33LGT06 APPLE RINGS - GUMMI CONFECTIONARY
19-AUG-2008 UNSAFE COL
CV. Prima Indo Tuna
Makassar ID-SN, ID 90242 LOS-DO 082-0303992-3/1/1
16AGT45 FRZ RAW YELLOWFIN TUNA LOINS BULK PACK 1X10 LB/CTN CO TREATE
20-AUG-2008 SALMONELLA
CV. Prima Indo Tuna
Makassar ID-SN, ID 90242 LOS-DO 082-0303992-3/2/1
16AGT45 FRZ RAW YELLOWFIN TUNA LOINS BULK PACK 1X30 LB/CTN CO TREATE
20-AUG-2008 SALMONELLA
Pt. Adamas Jaya Utama
Bekasi , ID 17310 LOS-DO 082-0303914-7/1/1
16AGT99 FRZ. RAW EMPEROR NATURAL FILLETS IWP SZ 4/6 6/8 8/10 10/12OZ
27-AUG-2008 FILTHY
Pt. Adamas Jaya Utama
Bekasi , ID 17310 LOS-DO 082-0303914-7/1/3
16AGT37 FRZ. RAW SCARLET SNAPPER FILLETS SZ 6/8 8/10 10/12 12/16OZ
27-AUG-2008 FILTHY
Pt. Adamas Jaya Utama
Bekasi , ID 17310 LOS-DO 082-0303914-7/1/4
16AGT37 FRZ. RAW SCARLET SNAPPER NATURAL FILLETS SZ 6/8 8/10 10/12OZ
27-AUG-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 FLA-DO 605-4059301-3/1/4
16SVT45 FROZEN TUNA STEAK
28-AUG-2008 SALMONELLA
P.T. Indah Tridharma Garmentama
Jakarta , ID 13910 NYK-DO 594-0188377-8/1/1
16AGT37 FROZEN SCARLET SNAPPER FILLET CO TREATED 4/6
Partial Refusal 28-AUG-2008 FILTHY
P.T. Indah Tridharma Garmentama
Jakarta , ID 13910 NYK-DO 594-0188377-8/1/2
16AGT37 FROZEN SCARLET SNAPPER FILLET CO TREATED 6/8
Partial Refusal 28-AUG-2008 FILTHY
P.T. Indah Tridharma Garmentama
Jakarta , ID 13910 NYK-DO 594-0188377-8/1/3
16AGT37 FROZEN SCARLET SNAPPER FILLET CO TREATED 8/10
Partial Refusal 28-AUG-2008 FILTHY
P.T. Indah Tridharma Garmentama
Jakarta , ID 13910 NYK-DO 594-0188377-8/1/4
16AGT37 FROZEN SCARLET SNAPPER FILLET CO TREATED 10/12
Partial Refusal 28-AUG-2008 FILTHY
P.T. Indah Tridharma Garmentama
Jakarta , ID 13910 NYK-DO 594-0188377-8/1/5
16AGT37 FROZEN SCARLET SNAPPER FILLET CO TREATED 12/16 (PLUS 1 CARTO
Partial Refusal 28-AUG-2008 FILTHY
P.T. Indah Tridharma Garmentama
Jakarta , ID 13910 NYK-DO 594-0188377-8/1/6
16AGT37 FROZEN SCARLET SNAPPER FILLET CO TREATED 1-3 (QUANTITY CORRE
Partial Refusal 28-AUG-2008 FILTHY