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
Sanmina Sci Systems De Mexico Sa
El Salto JAL, MX 45680 CIN-DO 110-1197290-3/1/1
95L--32 CD PLAYER COMBINATION SYSTEMS;;
03-JAN-2008 NO REGISTR
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/52/1
21VFY14 TAMARIND DRINK
07-JAN-2008 FILTHY
Toshiba Consumer Products
Jawa Barat , ID 17550 FLA-DO TW2-0011812-7/1/1
94V--07 COLOR TV SETS / FOR EXPORT ONLY
07-JAN-2008 NON STD
PT. Surya Alam Tunggal
Sidoarjo ID-JI, ID 61256 NYK-DO 417-0247170-1/1/1
16JGD05 FROZEN SHRIMP 2/4
08-JAN-2008 FILTHY
PT. Surya Alam Tunggal
Sidoarjo ID-JI, ID 61256 NYK-DO 417-0247170-1/1/2
16JGD05 FROZEN SHRIMP 4/6
08-JAN-2008 FILTHY
PT. Surya Alam Tunggal
Sidoarjo ID-JI, ID 61256 NYK-DO 417-0247170-1/1/3
16JGD05 FROZEN SHRIMP 6/8
08-JAN-2008 FILTHY
PT HARAPAN BENDERANG
Surabaya Id-Su, ID NONE NYK-DO 417-0247199-0/1/1
16JGT05 RAW SHRIMP (P&D TAIL OFF) 26/30
08-JAN-2008 FILTHY
PT HARAPAN BENDERANG
Surabaya Id-Su, ID NONE NYK-DO 417-0247199-0/2/1
16JGD05 RAW EZ PEEL SHRIMP 31/40
08-JAN-2008 FILTHY
Scheering Indonesia
Jakarta , ID SAN-DO 112-0292187-3/1/1
61BDB02 738115282596 BIRTH CONTROL PILLS
10-JAN-2008 UNAPPROVED
Pt. Embassy Seafood International
Jawa Barat , ID FLA-DO 826-0119371-5/1/1
16JEO01 REFRIGERATED CRABMEAT (PAUSTEURIZED)
15-JAN-2008 VETDRUGRES
Pt. Royal Fisheries Indonesia Marine Product Processor & E
Gempol , ID FLA-DO 595-4390297-3/1/1
16XGD21 FROZEN HEADLESS SHELL-ON RAW SHRIMP 26/30
15-JAN-2008 FILTHY
SALMONELLA
Pt. Royal Fisheries Indonesia Marine Product Processor & E
Gempol , ID FLA-DO 595-4390079-5/1/1
16XGD21 FROZEN HEADLESS SHELL-ON RAW SHRIMP 26/30
15-JAN-2008 FILTHY
SALMONELLA
Toshiba Consumer Products
Jawa Barat , ID 17550 FLA-DO TW2-0011888-7/1/1
94V--07 COLOR TV SETS / FOR EXPORT ONLY
18-JAN-2008 NO REGISTR
P T Natraco Padang
Padang , ID 25117 NYK-DO 110-1235640-4/1/1
36AGT99 Cinnamon Sugar
24-JAN-2008 SALMONELLA
Pt Fajar Carawala
Jakarta , ID LOS-DO HK1-0173331-7/1/2
16AGT45 FROZEN TUNA STEAK ROUND AA: 08-10 OZ
27-JAN-2008 FILTHY
Pt Fajar Carawala
Jakarta , ID LOS-DO HK1-0173331-7/1/3
16AGT45 FROZEN TUNA STEAK ROUND AA: 06-08 OZ; cold storage lot #2479
27-JAN-2008 FILTHY
Pt Fajar Carawala
Jakarta , ID LOS-DO HK1-0173331-7/1/4
16AGT45 FROZEN TUNA STEAK ROUND A: 08-10 OZ
27-JAN-2008 FILTHY
Pt Fajar Carawala
Jakarta , ID LOS-DO HK1-0173331-7/1/5
16AGT45 FROZEN TUNA STEAK ROUND A: 06-08 OZ
27-JAN-2008 FILTHY
Pt Fajar Carawala
Jakarta , ID LOS-DO HK1-0173331-7/1/6
16AGT45 FROZEN TUNA SCRAPE GRADE AA; cold storage lot #247933
27-JAN-2008 FILTHY
Pt Fajar Carawala
Jakarta , ID LOS-DO HK1-0173331-7/1/7
16AGT45 FROZEN TUNA LOIN SIZE 5-12 LBS
27-JAN-2008 FILTHY
Pt Fajar Carawala
Jakarta , ID LOS-DO HK1-0173331-7/1/8
16AGT45 FROZEN TUNA LOIN SIZE 12 UP LBS
27-JAN-2008 FILTHY
Pt Fajar Carawala
Jakarta , ID LOS-DO HK1-0173331-7/1/9
16AGT45 FROZEN TUNA CHUNK LOIN SIZE 03-05 LBS
27-JAN-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO HK1-0173350-7/1/1
16AGT45 FROZEN YELLOWFIN TUNA STEAK SIZE 2 OZ
27-JAN-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO HK1-0173350-7/1/2
16AGT45 FROZEN YELLOWFIN TUNA STEAK SIZE 6 OZ
27-JAN-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO HK1-0173350-7/1/3
16AGT45 FROZEN YELLOWFIN TUNA STEAK SIZE 8 OZ
27-JAN-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO HK1-0173350-7/1/4
16AGT45 FROZEN YELLOWFIN TUNA STEAK SIZE 10 OZ
27-JAN-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO HK1-0173350-7/1/5
16AGT45 FROZEN YELLOWFIN TUNA STEAK SIZE 12 OZ
27-JAN-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO HK1-0173350-7/1/6
16AGT45 FROZEN WILD YELLOWFIN TUNA STEAK (BBR) SIZE 4 OZ
27-JAN-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO HK1-0173350-7/1/7
16AGT45 FROZEN SKEWERED WILD TUNA STEAK SD
27-JAN-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO HK1-0173350-7/1/8
16AGT45 FROZEN WILD YELLOWFIN TUNA SCRAPE (HS)
27-JAN-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO HK1-0173350-7/1/9
16AGT45 FROZEN YELLOWFIN TUNA STEAK 'S' GRADE SIZE: CUBE, WILD CAUGH
27-JAN-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO HK1-0173350-7/1/10
16AGT45 FROZEN WILD YELLOWFIN TUNA LOIN (NO CO) SIZE 5/12
27-JAN-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO HK1-0173350-7/1/11
16AGT45 FROZEN WILD YELLOWFIN TUNA LOIN (NO CO) SIZE 12/UP
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/1/1
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 2-4 OZ, A GRADE
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/1/2
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 4-6 OZ, A GRADE
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/1/3
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 6 OZ, A GRADE
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/1/4
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 8 OZ, A GRADE
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/1/5
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 10 OZ, A GRADE
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/1/6
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 6 OZ, AA GRADE
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/1/7
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 8 OZ, AA GRADE
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/1/8
16AGT45 FROZEN CO YELLOWFIN TUNA STEAK 10 OZ, AA GRADE
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/1/9
16AGT45 FROZEN CO YELLOWFIN TUNA CUBES, A GRADE
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/1/10
16AGT45 FROZEN CO YELLOWFIN TUNA SKEWERS, A GRADE
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/2/1
16AGT51 FROZEN CO MAHI MAHI FILLET SIZE 3-5 LBS, SKIN ON, BONELESS
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/2/2
16AGT51 FROZEN CO MAHI MAHI FILLET SIZE 5 LBS,SKIN ON,BONELESS
27-JAN-2008 FILTHY
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO HK1-0173475-2/2/3
16AGT51 FROZEN CO MAHI MAHI PORTION SIZE 2/4 OZ SKINLESS,BONELESS
27-JAN-2008 FILTHY
Pt. Intimas Surya (Bali)
Bali , ID SEA-DO 605-4054799-3/1/2
16SVT45 FROZEN CLEAR SMOKED TUNA SAKU SKINLESS BONELESS
29-JAN-2008 FILTHY
CV. Indotropic Fishery
Luwuk ID-ST, ID 94751 BLT-DO AMQ-0555295-8/1/1
16AGT37 SNAPPER CUT FILLETS
31-JAN-2008 SALMONELLA
CV. Indotropic Fishery
Luwuk ID-ST, ID 94751 BLT-DO AMQ-0555295-8/1/2
16AGT37 SNAPPER CUT FILLETS
31-JAN-2008 SALMONELLA
CV. Indotropic Fishery
Luwuk ID-ST, ID 94751 BLT-DO AMQ-0555295-8/1/3
16AGT37 SNAPPER CUT FILLETS
31-JAN-2008 SALMONELLA
CV. Indotropic Fishery
Luwuk ID-ST, ID 94751 BLT-DO AMQ-0555295-8/1/4
16AGT37 SNAPPER CUT FILLETS
31-JAN-2008 SALMONELLA
CV. Indotropic Fishery
Luwuk ID-ST, ID 94751 BLT-DO AMQ-0555295-8/1/5
16AGT37 SNAPPER CUT FILLETS
31-JAN-2008 SALMONELLA
CV. Indotropic Fishery
Luwuk ID-ST, ID 94751 BLT-DO AMQ-0555295-8/1/6
16AGT37 SNAPPER CUT FILLETS
31-JAN-2008 SALMONELLA
CV. Indotropic Fishery
Luwuk ID-ST, ID 94751 BLT-DO AMQ-0555295-8/1/7
16AGT37 SNAPPER CUT FILLETS
31-JAN-2008 SALMONELLA
CV. Indotropic Fishery
Luwuk ID-ST, ID 94751 BLT-DO AMQ-0555295-8/1/8
16AGT37 SNAPPER CUT FILLETS
31-JAN-2008 SALMONELLA