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
Avila Prima
Java , ID NWE-DO FD6-3058735-6/1/1
16AEE45 CANNED TUNA
01-MAY-2008 FILTHY
Pt. Dua Kelinci
Pati, Indonesia , ID LOS-DO 442-0138888-9/12/2
23BEB07 DK HOT NUT CHILI FLAVOUR
05-MAY-2008 UNSAFE COL
P.T. WIRA AKSARA
Jakarta ID-JK, ID 12430 LOS-DO 442-0138888-9/14/1
36AGT03 GULA JAWA (ARENGA SUGAR AND CANE SUGAR)
05-MAY-2008 FILTHY
USUAL NAME
NUTRIT LBL
PT Sepasang Naga Jaya
Jakarta Utara, ID 14410 LOS-DO 442-0138888-9/15/1
23BGB99 KEMIRI CANDLE NUTS
05-MAY-2008 POISONOUS
Wsc Casablanca D
Jakarta , ID SAN-DO 112-1946054-3/1/1
64GDB29 Levonorgestrel and Ethinyllestradiol tablets packed in blist
07-MAY-2008 NOT LISTED
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348698-3/18/1
21VFY04 GUAVA JUICE
07-MAY-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348698-3/19/1
21VFY19 LYCHEE JUICE
07-MAY-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348698-3/20/1
22KFY04 Mango juice
07-MAY-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348698-3/21/1
22KFY04 SOURSOP JUICE
07-MAY-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348698-3/38/1
31KYE02 JASMINE TEA
07-MAY-2008 TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
P. T. Lautan Bahari Sejahtera
Jakarta ID-JK, ID 14440 LOS-DO AT2-0040012-8/2/2
16AGD45 FROZEN TUNA GROUND MEAT
07-MAY-2008 SALMONELLA
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 595-4420165-6/1/1D
16AGT45 TUNA SASHIMI BE SAKU A1A
07-MAY-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 595-4420165-6/1/1F
16AGT45 TUNA SASHIMI BE SAKU A2A
07-MAY-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 595-4420165-6/1/1H
16AGT45 TUNA SASHIMI PIECES
07-MAY-2008 FILTHY
P.T. Super Saku Bali
DENPASAR ID-BA, ID 80223 LOS-DO 389-0039194-7/1/3
16AVT45 FROZEN VAC.PAC TUNA FILLETS(GROUND MEAT) GM
08-MAY-2008 FILTHY
P.T. Super Saku Bali
DENPASAR ID-BA, ID 80223 LOS-DO 389-0039194-7/1/4
16AVT45 FROZEN VAC.PAC TUNA FILLETS(SAKU AA)
08-MAY-2008 FILTHY
P.T. Super Saku Bali
DENPASAR ID-BA, ID 80223 LOS-DO 389-0039196-2/1/1
16AVT45 FROZEN VAC.PAC TUNA FILLETS(CHUNK MEAT) CM
08-MAY-2008 FILTHY
Pt. Bitung Mina Utama
Bitung Timur North Sulawesi , ID LOS-DO ES2-0105161-3/1/1
16AGT45 FROZEN YELLOWFIN TUNA SAKU(AAA)
08-MAY-2008 HISTAMINE
Pt. Bitung Mina Utama
Bitung Timur North Sulawesi , ID LOS-DO ES2-0105161-3/1/2
16AGT45 FROZEN YELLOWFIN TUNA SAKU(AA)
08-MAY-2008 FILTHY
Pt. Bitung Mina Utama
Bitung Timur North Sulawesi , ID LOS-DO ES2-0105161-3/1/3
16AGT45 FROZEN YELLOWFIN TUNA SAKU(A3)
08-MAY-2008 FILTHY
Pt. Bitung Mina Utama
Bitung Timur North Sulawesi , ID LOS-DO ES2-0105161-3/2/1
16AGT45 FROZEN BIGEYE TUNA SAKU(AAA)
08-MAY-2008 FILTHY
Pt. Bitung Mina Utama
Bitung Timur North Sulawesi , ID LOS-DO ES2-0105161-3/2/2
16AGT45 FROZEN BIGEYE TUNA SAKU(AA)
08-MAY-2008 FILTHY
Pt. Bitung Mina Utama
Bitung Timur North Sulawesi , ID NYK-DO 594-0185899-4/1/4
16AGD45 FROZEN BIGEYE TUNA
09-MAY-2008 SALMONELLA
P.T. Super Saku Bali
DENPASAR ID-BA, ID 80223 LOS-DO 389-0039243-2/1/2
16AVT45 FROZEN VAC.PAC TUNA FILLETS(CUBE CUT) CCH
12-MAY-2008 FILTHY
P.T. Super Saku Bali
DENPASAR ID-BA, ID 80223 LOS-DO 389-0039243-2/1/3
16AVT45 FROZEN VAC.PAC TUNA FILLETS(CHUNK MEAT) CM
12-MAY-2008 FILTHY
Pt. Bitung Mina Utama
Bitung Timur North Sulawesi , ID LOS-DO ES2-0105827-9/1/2
16AGT45 FROZEN YELLOWFIN TUNA SAKU(AA)
13-MAY-2008 FILTHY
Pt. Bitung Mina Utama
Bitung Timur North Sulawesi , ID LOS-DO ES2-0105827-9/1/4
16AGT45 FROZEN YELLOWFIN TUNA SAKU(AA)(17)
13-MAY-2008 FILTHY
Pt. Bitung Mina Utama
Bitung Timur North Sulawesi , ID LOS-DO ES2-0105827-9/2/1
16AGT45 FROZEN BIGEYE TUNA SAKU(AAA)
13-MAY-2008 FILTHY
Pt. Bitung Mina Utama
Bitung Timur North Sulawesi , ID LOS-DO ES2-0105827-9/2/2
16AGT45 FROZEN BIGEYE TUNA SAKU(AA)
13-MAY-2008 FILTHY
PT Dharma Samudera Fishing Industries TBK
Jakarta , ID SJN-DO N35-0223721-6/1/1
16AGT37 FROZEN SNAPPER ONE CUT
14-MAY-2008 FILTHY
CV. Prima Indo Tuna
Makassar ID-SN, ID 90242 NYK-DO H67-1311105-1/2/1
16AFD45 FROZEN TUNA STEAKS
22-MAY-2008 SALMONELLA
CV. Prima Indo Tuna
Makassar ID-SN, ID 90242 NYK-DO H67-1311105-1/3/1
16AFD45 FROZEN TUNA STEAKS
22-MAY-2008 SALMONELLA
CV. Prima Indo Tuna
Makassar ID-SN, ID 90242 NYK-DO H67-1311105-1/4/1
16AFD45 FROZEN TUNA STEAKS
22-MAY-2008 SALMONELLA
CV. Prima Indo Tuna
Makassar ID-SN, ID 90242 NYK-DO H67-1311105-1/5/1
16AFD45 FROZEN TUNA STEAKS
22-MAY-2008 SALMONELLA
PT MUARA MANGGALINDO
Jakarta Jakarta, ID 14440 NYK-DO 594-0186471-1/1/3
16AGT72 FROZEN KING FISH STEAKS
27-MAY-2008 FILTHY
PT MUARA MANGGALINDO
Jakarta Jakarta, ID 14440 NYK-DO 594-0186471-1/1/4
16AGT72 FROZEN KING FISH STEAKS
27-MAY-2008 FILTHY
PT MUARA MANGGALINDO
Jakarta Jakarta, ID 14440 NYK-DO 594-0186471-1/1/5
16AGT72 FROZEN KING FISH STEAKS
27-MAY-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 595-4412830-5/1/1B
16AGT45 FROZEN TUNA SASHIMI BIG EYE SAKU AAA; cold storage lot #1863
27-MAY-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 595-4412830-5/1/1C
16AGT45 FROZEN TUNA SASHIMI YELLOWFIN SAKU A1A; cold storage lot #18
27-MAY-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 595-4412830-5/1/1D
16AGT45 FROZEN TUNA SASHIMI BIG EYE SAKU A1A; cold storage lot #1863
27-MAY-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 595-4412830-5/1/1E
16AGT45 FROZEN TUNA SASHIMI YELLOWFIN SAKU A2A; cold storage lot #18
27-MAY-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 595-4412830-5/1/1F
16AGT45 FROZEN TUNA SASHIMI BIG EYE SAKU A2A; cold storage lot #1863
27-MAY-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 595-4412830-5/1/1H
16AGT45 FROZEN TUNA SASHIMI PIECES; cold storage lot #186373-8
27-MAY-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 595-4412830-5/1/1J
16AGT45 FROZEN TUNA LOIN CC 5/8 LBS; cold storage lot #186373-10
27-MAY-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 595-4412830-5/1/1K
16AGT45 FROZEN TUNA LOIN CC 8/12 LBS; cold storage lot #186373-11
27-MAY-2008 FILTHY
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 SEA-DO 605-4057389-0/1/1
16AVT45 FROZEN TUNA SAKU
30-MAY-2008 LACKS FIRM
SALMONELLA
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 SEA-DO 605-4057389-0/1/2
16AVT45 FROZEN TUNA STEAK
30-MAY-2008 LACKS FIRM
SALMONELLA
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 SEA-DO 605-4057389-0/1/3
16AVT45 FROZEN TUNA LOIN CENTER CUT
30-MAY-2008 LACKS FIRM
SALMONELLA
Pt Multi Monodon Indonesia
Makassar , ID LOS-DO JK8-0114508-2/1/1
16XGT21 FROZEN HEADLESS, SHELL-ON SHRIMP (31/35)
30-MAY-2008 FILTHY
Pt Multi Monodon Indonesia
Makassar , ID LOS-DO JK8-0114508-2/2/1
16XGT21 FROZEN HEADLESS, SHELL-ON SHRIMP
30-MAY-2008 FILTHY