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
Toshiba Consumer Products
Jawa Barat , ID 17550 FLA-DO TW2-0012599-9/1/1
95L--31 COLOR TV SETS / FOR EXPORT ONLY/ FOR EXPORT ONLY / FOR EXPOR
02-JUL-2008 NON STD
PT. Tempo Scan Pacific
Jakarta , ID SWI-DO XXX-0154562-4/1/1D
64LAJ67 Tempovate Gel
07-JUL-2008 DIRECTIONS
UNAPPROVED
PT. TOBA SURIMI INDUSTRIES
MEDAN SUMATERA UTARA , ID FLA-DO D97-0453038-2/1/1
16JFD01 FROZEN SOFT SHELL CRABMEAT
09-JUL-2008 SALMONELLA
Pt. Intisamudera Citra Perkasa
Bali , ID LOS-DO 221-1884670-2/1/1
16AGT45 RAW CO TUNA SAKU SASIMI FILLET (MARK BLACK TIE)
10-JUL-2008 FILTHY
Pt. Intisamudera Citra Perkasa
Bali , ID LOS-DO 221-1884670-2/1/2
16AGT45 RAW CO TUNA STEAK (MARK BLACK TIE) 4OZ
10-JUL-2008 FILTHY
Pt. Intisamudera Citra Perkasa
Bali , ID LOS-DO 221-1884670-2/1/3
16AGT45 RAW CO TUNA STEAK (MARK BLACK TIE) 8OZ
10-JUL-2008 FILTHY
Pt. Intisamudera Citra Perkasa
Bali , ID LOS-DO 221-1884670-2/1/5
16AGT45 RAW CO TUNA STEAK (MARK PARADISE) 4OZ
10-JUL-2008 FILTHY
Pt. Intisamudera Citra Perkasa
Bali , ID LOS-DO 221-1884670-2/1/9
16AGT45 RAW CO TUNA STEAK (MARK SC) 4OZ
10-JUL-2008 FILTHY
Pt. Intisamudera Citra Perkasa
Bali , ID LOS-DO 221-1884670-2/1/10
16AGT45 RAW CO TUNA STEAK (MARK SC) 6OZ
10-JUL-2008 FILTHY
Pt. Intisamudera Citra Perkasa
Bali , ID LOS-DO 221-1884670-2/1/12
16AGT45 RAW CO TUNA STEAK (MARK SC) 10OZ
10-JUL-2008 FILTHY
Pt. Intisamudera Citra Perkasa
Bali , ID LOS-DO 221-1884670-2/1/13
16AGT45 PREMIUM TUNA STEAK (MARK PARADISE) 8OZ
10-JUL-2008 FILTHY
CV. Indotropic Fishery
Luwuk ID-ST, ID 94751 NYK-DO AMQ-0558614-7/1/10
16AGT17 GROUPER CUT FILLET
15-JUL-2008 FILTHY
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348458-2/4/1
20SFY01 GUAVA JUICE
15-JUL-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348458-2/5/1
21VFY04 GUAVA JUICE
15-JUL-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348458-2/6/1
21VFY19 LYCHEE JUICE
15-JUL-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348458-2/7/1
21VFY04 MANGO JUICE
15-JUL-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348458-2/8/1
22KFY04 SOURSOP JUICE
15-JUL-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4349831-9/6/1
21VFY04 GUAVA JUICE
15-JUL-2008 NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4349831-9/7/1
21VFY19 LYCHEE JUICE
15-JUL-2008 NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4349831-9/8/1
20KFY06 Mandarin Ornage Juice with Cells
15-JUL-2008 NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4349831-9/9/1
21VFY05 MANGO JUICE
15-JUL-2008 NEEDS FCE
NO PROCESS
Pt. Makmur Jaya Sejahtera
Bali , ID 80361 LOS-DO 221-1889230-0/1/1
16AGT45 FROZEN TUNA (TUNA SAKU)
15-JUL-2008 FILTHY
Pt. Makmur Jaya Sejahtera
Bali , ID 80361 LOS-DO 221-1889230-0/1/2
16AGT45 FROZEN TUNA (TUNA SAKU)
15-JUL-2008 FILTHY
Pt. Makmur Jaya Sejahtera
Bali , ID 80361 LOS-DO 221-1889230-0/1/6
16AGT45 FROZEN TUNA TUNA CUBE)
15-JUL-2008 FILTHY
Pt. Makmur Jaya Sejahtera
Bali , ID 80361 LOS-DO 221-1889230-0/1/7
16AGT45 FROZEN TUNA (TUNA STRIP MEAT)
15-JUL-2008 FILTHY
PT Dharma Samudera Fishing Industries TBK
Jakarta , ID SWI-DO KM6-0107970-0/1/1
16AGT45 TUNA STEAK IQF 8OZ
16-JUL-2008 HISTAMINE
PT Dharma Samudera Fishing Industries TBK
Jakarta , ID SWI-DO KM6-0107970-0/1/2
16AGT45 TUNA STEAK IQF 10OZ
16-JUL-2008 HISTAMINE
PT Dharma Samudera Fishing Industries TBK
Jakarta , ID SWI-DO KM6-0107970-0/1/3
16AGT45 TUNA LOIN IQF 3/5 LB.
16-JUL-2008 HISTAMINE
PT Dharma Samudera Fishing Industries TBK
Jakarta , ID SWI-DO KM6-0107970-0/1/4
16AGT45 TUNA LOIN IQF 5/8 LB.
16-JUL-2008 HISTAMINE
PT. MAKMUR JAYA SEJAHTERA
JAKARTA ID-JK, ID 14440 LOS-DO ATG-1004446-5/5/1
16AVT45 FROZEN YELLOWFIN TUNA STEAKS 6 OZ, CO TREATED
17-JUL-2008 SALMONELLA
PT. MAKMUR JAYA SEJAHTERA
JAKARTA ID-JK, ID 14440 LOS-DO ATG-1004446-5/12/1
16AVT45 FROZEN YELLOWFIN TUNA STEAKS SAKU, CO TREATED
17-JUL-2008 SALMONELLA
PT. INDOMAGURO TUNAS UNGGUL
Jakarta , ID 14440 SEA-DO 471-0085773-0/1/1
16AGT45 3136 CARTONS FROZEN TUNA STEAKS, LOIS, SAKU & CUBE
Partial Refusal 17-JUL-2008 FILTHY
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4349831-9/10/1
22KFY04 SOURSOP JUICE
18-JUL-2008 NEEDS FCE
NO PROCESS
Pt. Zeta Agro Corporation
Brebes , ID NYK-DO 916-1667856-0/4/1
25QCE99 PORTABELLA MUSHROOMS SLICES
21-JUL-2008 NONRSP-PRC
Toshiba Consumer Products
Jawa Barat , ID 17550 FLA-DO TW2-0012653-4/1/1
94V--07 COLOR TV SETS / FOR EXPORT ONLY / FOR EXPORT ONLY / FOR EXPO
22-JUL-2008 NON STD
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 FLA-DO 605-4058255-2/1/5
16SVT45 FROZEN TUNA LOIN CENTER CUT
22-JUL-2008 SALMONELLA
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 FLA-DO 605-4058446-7/1/2
16SVT45 FROZEN TUNA SAKU
22-JUL-2008 SALMONELLA
P.T. Super Saku Bali
DENPASAR ID-BA, ID 80223 LOS-DO 389-0039273-9/1/1
16AVT45 FROZEN VAC.PAC TUNA FILLETS(SAKU)
23-JUL-2008 FILTHY
P.T. Super Saku Bali
DENPASAR ID-BA, ID 80223 LOS-DO 389-0039271-3/1/1
16AVT45 FROZEN VAC.PAC TUNA FILLETS,LOINS, & STEAKS
23-JUL-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 NYK-DO 594-0188785-2/1/3
16AGT45 FROZEN TUNA FILLETS STEAK 6 OZ
29-JUL-2008 SALMONELLA
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 NYK-DO 594-0188785-2/1/4
16AGT45 FROZEN TUNA FILLETS STEAK 8 OZ
29-JUL-2008 SALMONELLA