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
CV. Indotropic Fishery
Luwuk ID-ST, ID 94751 LOS-DO 082-0301114-6/1/2
16AGT37 FRZ. OPAKAPAKA ONE CUT FILLETS 6/8,8/10,10/12,12/14,14/16,16
02-APR-2008 SALMONELLA
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0174750-7/1/1
16AGT45 FROZEN CO YELLOWFIN TUNA SAKU, AA GRADE
02-APR-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0174750-7/1/2
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 6 OZ, A GRADE
02-APR-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0174750-7/1/3
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 8 OZ, A GRADE
02-APR-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0174750-7/1/4
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 10 OZ, A GRADE
02-APR-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0174750-7/1/5
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 6 OZ, AA GRADE
02-APR-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0174750-7/1/6
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 8 OZ, AA GRADE
02-APR-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0174750-7/1/7
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 10 OZ, AA GRADE
02-APR-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0174750-7/1/8
16AGT45 FROZEN CO YELLOWFIN TUNA CUBES, A GRADE
02-APR-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0174750-7/1/9
16AGT45 FROZEN CO YELLOWFIN TUNA SKEWERS, A GRADE
02-APR-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0172025-6/2/1
16AGT37 FROZEN MALABAR SNAPPER FILLET SIZE 6/8 OZ,SKINLESS,BONELESS
02-APR-2008 LABELING
SALMONELLA
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0172025-6/2/2
16AGT37 FROZEN MALABAR SNAPPER FILLET SIZE 8/10 OZ,SKINLESS,BONELESS
02-APR-2008 LABELING
SALMONELLA
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0172025-6/2/3
16AGT37 FROZEN MALABAR SNAPPER FILLET SIZE 10/12 OZ,SKINLESS,BONELES
02-APR-2008 LABELING
SALMONELLA
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0172025-6/2/4
16AGT37 FROZEN MALABAR SNAPPER FILLET SIZE 12/16 OZ,SKINLESS,BONELES
02-APR-2008 LABELING
SALMONELLA
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0172025-6/2/5
16AGT37 FROZEN MALABAR SNAPPER FILLET SIZE 16/20 OZ,SKINLESS,BONELES
02-APR-2008 LABELING
SALMONELLA
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0172025-6/2/6
16AGT37 FROZEN MALABAR SNAPPER FILLET,SIZE 20/30 SKINLESS,BONELESS
02-APR-2008 LABELING
SALMONELLA
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0172025-6/2/7
16AGT37 FROZEN MALABAR SNAPPER FILLET SIZE 30/40 OZ,SKINLESS,BONELES
02-APR-2008 LABELING
SALMONELLA
Tuna Permata Rezeki
Jakarta , ID LOS-DO 389-0039179-8/1/1
16AVT45 FROZEN VAC.PAC TUNA FILLETS(SAKU WAA)
03-APR-2008 FILTHY
Tuna Permata Rezeki
Jakarta , ID LOS-DO 389-0039179-8/1/2
16AVT45 FROZEN VAC.PAC TUNA FILLETS(SAKU AA) AFC
03-APR-2008 FILTHY
Tuna Permata Rezeki
Jakarta , ID LOS-DO 389-0039179-8/1/3
16AVT45 FROZEN VAC.PAC TUNA FILLETS(CUBE CUT) CC
03-APR-2008 FILTHY
Tuna Permata Rezeki
Jakarta , ID LOS-DO 389-0039179-8/1/4
16AVT45 FROZEN VAC.PAC TUNA FILLETS(CHUNK MEAT) CM
03-APR-2008 FILTHY
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 LOS-DO HK1-0175940-3/2/2
80L--YY LATEX EXAMINATION GLOVES, POWDER FREE, SIZE: XL
08-APR-2008 HOLES
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 389-0039236-6/1/1
16AVT45 FROZEN VAC.PAC TUNA FILLETS(SAKU WAA) LOT 1526
10-APR-2008 FILTHY
Lucky Samudra Pratama
Jakarta , ID 14440 FLA-DO 605-4056127-5/2/2
16AVD45 FROZEN YELLOWFIN TUNA LOIN
11-APR-2008 SALMONELLA
Lucky Samudra Pratama
Jakarta , ID 14440 FLA-DO 605-4056127-5/2/3
16AVD45 FROZEN YELLOWFIN TUNA SAKU AND STEAKS
11-APR-2008 SALMONELLA
P.T. Sinar Sosro
Bekasi , ID LOS-DO 442-0130580-0/20/1
21TGT05 DRIED HOT MANGO (PEDAS)
11-APR-2008 CYCLAMATE
SACCHARLBL
P.T. Sinar Sosro
Bekasi , ID LOS-DO 442-0130580-0/20/2
21TGT05 DRIED SWEET MANGO (MANIS)
11-APR-2008 CYCLAMATE
SACCHARIN
Pt. Pondan Pangan Makmur
Tangerang , ID LOS-DO 442-0130580-0/21/3
03SFT01 PONDAN GREEN SPONGE CAKE MIX
11-APR-2008 UNSAFE COL
LIST INGRE
Tunggal Jaya Prima
Medan ID-SU, ID 20362 LOS-DO 442-0140676-4/13/1
36BCT99 SYRUP MARUISA SARANG TAWON
11-APR-2008 UNSAFE COL
Kimia Farma
Bekasi , ID SAN-DO 112-2162280-9/1/1
60LBB99 862480830941 NEURALGIN ANALGESIC
16-APR-2008 NOT LISTED
UNAPPROVED
Pt Gunung Slamat
Slawi , ID LOS-DO 442-0128580-4/16/2
66V--99 Teh Sosro Celup Premium Green Tea
19-APR-2008 NOT LISTED
FALSE
UNAPPROVED
Tuna Permata Rezeki
Jakarta , ID SAN-DO D11-0114025-3/1/1
16AGT45 FROZEN TUNA CUBE
21-APR-2008 SALMONELLA
PT. INDOMAGURO TUNAS UNGGUL
Jakarta , ID 14440 SEA-DO 231-6278578-9/1/2
16AGT45 RED YELLOWFIN CUBES
22-APR-2008 FILTHY
PT. INDOMAGURO TUNAS UNGGUL
Jakarta , ID 14440 SEA-DO 231-6278578-9/1/3
16AGT45 IRREGULAR YELLOWFIN CUBES
22-APR-2008 FILTHY
PT. INDOMAGURO TUNAS UNGGUL
Jakarta , ID 14440 SEA-DO 231-6278578-9/1/6
16AGT45 8 OZ YELLOWFIN TUNA STEAKS
Partial Refusal 22-APR-2008 FILTHY
Cv. Sira Guna Putra
Jakarta , ID FLA-DO WKV-0071245-0/1/1
16JGO01 CRABMEAT
23-APR-2008 VETDRUGRES
PT. ERA MANDIRI CEMERLANG
JAKARTA UTARA ID-JK, ID 14440 LOS-DO 082-0301696-2/2/1
16AGT45 FRZ RAW YELLOWFIN TUNA LOINS, BULK PACK 1X44 LB/CTN
23-APR-2008 SALMONELLA
PT. ERA MANDIRI CEMERLANG
JAKARTA UTARA ID-JK, ID 14440 LOS-DO 082-0301696-2/2/2
16AGT45 FRZ RAW YELLOWFIN TUNA STEAKS
23-APR-2008 SALMONELLA
PT. ERA MANDIRI CEMERLANG
JAKARTA UTARA ID-JK, ID 14440 LOS-DO 082-0301696-2/2/3
16AGT45 FRZ RAW YELLOWFIN TUNA SAKU BLOCKS
23-APR-2008 SALMONELLA
Kelola Mina Laut, PT
Gresik , ID 61121 NYK-DO 594-0184934-0/3/2
16AGT99 FROZEN KING FISH STEAKS 8-10
30-APR-2008 FILTHY
Kelola Mina Laut, PT
Gresik , ID 61121 NYK-DO 594-0184934-0/3/1
16AGT99 FROZEN KING FISH STEAKS 6-8
30-APR-2008 FILTHY
Kelola Mina Laut, PT
Gresik , ID 61121 NYK-DO 594-0184934-0/3/3
16AGT99 FROZEN KING FISH STEAKS 10-12
30-APR-2008 FILTHY
Kelola Mina Laut, PT
Gresik , ID 61121 NYK-DO 594-0184934-0/3/4
16AGT99 FROZEN KING FISH STEAKS 12-14
30-APR-2008 FILTHY
Kelola Mina Laut, PT
Gresik , ID 61121 NYK-DO 594-0184934-0/3/5
16AGT99 FROZEN KING FISH STEAKS 14-16
30-APR-2008 FILTHY
Kelola Mina Laut, PT
Gresik , ID 61121 NYK-DO 594-0184934-0/3/6
16AGT99 FROZEN KING FISH STEAKS 16-18
30-APR-2008 FILTHY
PT. Heinz ABC Indonesia
Karawang ID-JB, ID 41371 LOS-DO T81-4348004-4/1/1
36BCT99 Sirup Special Grade rasa cocopandan
30-APR-2008 UNSAFE COL
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348004-4/55/1
31KHE99 TEH KOTAH JASMINE TEA
30-APR-2008 NEEDS FCE
NO PROCESS