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
PT Dharma Samudera Fishing Industries TBK
Jakarta , ID SJN-DO WIM-0036387-0/1/1
16AGD37 FROZEN SCARLET WGGS SIZE 0.5/1 LBS.
03-DEC-2007 FILTHY
PT Dharma Samudera Fishing Industries TBK
Jakarta , ID SJN-DO WIM-0036387-0/1/2
16AGD37 FROZEN SCARLET SNAPPER WGGS SIZE 1/1.5 LBS
03-DEC-2007 FILTHY
PT Dharma Samudera Fishing Industries TBK
Jakarta , ID SJN-DO WIM-0036387-0/1/3
16AGD37 FROZEN SCARLET SNAPPER WGGS SIZE 1/2 LBS
03-DEC-2007 FILTHY
PT Dharma Samudera Fishing Industries TBK
Jakarta , ID SJN-DO WIM-0036387-0/1/4
16AGD37 FROZEN MALABAR SNAPPER WGGS SIZE 0.5/1 LB
03-DEC-2007 FILTHY
PT Dharma Samudera Fishing Industries TBK
Jakarta , ID SJN-DO WIM-0036387-0/1/5
16AGD37 FROZEN MALABAR SNAPPER WGGS.
03-DEC-2007 FILTHY
Pt. Krishna Garmindo Garments, Textiles & Sundries
Jakarta , ID NYK-DO F30-0043279-7/1/1
34HGH03 POWDERED MILK
08-DEC-2007 FILTHY
Pt. Intisamudera Citra Perkasa
Bali , ID NYK-DO 221-1875531-7/1/1
16AGT45 CYRO FREEZE TUNA STEAK (MARK OCEAN CROWN) 6OZ
11-DEC-2007 FILTHY
Toshiba Consumer Products
Jawa Barat , ID 17550 FLA-DO TW2-0011841-6/1/1
94V--07 COLOR TV SETS / FOR EXPORT ONLY
12-DEC-2007 NON STD
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/8/1
21VFY04 GUAVA JUICE
17-DEC-2007 NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/9/1
21VFY05 MANGO JUICE
17-DEC-2007 LABELING
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/17/1
28JGT99 FRIED CHICKEN SEASONING PASTE
17-DEC-2007 TRANSFAT
LABELING
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/18/1
28JCT99 FRIED RICE SEASONING PASTE (HOT)
17-DEC-2007 TRANSFAT
LABELING
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/19/1
28JCT99 FRIED RICE SEASONING PASTE (MILD)
17-DEC-2007 TRANSFAT
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/20/1
28JCT99 INDONESIAN ESSENTIAL SEASONING "INTI A"
17-DEC-2007 NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/21/1
28JCT99 ESSENTIAL SEASONING "INITI B"
17-DEC-2007 NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/22/1
28JGT99 ESSENTIAL SEASONING "INITI C"
17-DEC-2007 NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/23/1
28JCT99 ESSENTIAL SEASONING "INITI D"
17-DEC-2007 TRANSFAT
LABELING
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/51/1
24DGT99 GREEN BEAN DRINK
17-DEC-2007 LABELING
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/29/1
28JGT99 YELLOW RICE SEASONING PASTE
17-DEC-2007 NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/28/1
24CCT13 Sambol Tauco (Salted Soya-Beans Relish)
17-DEC-2007 NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/26/1
28JCT99 SUPER TAUCO SAUCE
17-DEC-2007 NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4344977-5/25/1
28JGT99 SATAY SAUCE
17-DEC-2007 TRANSFAT
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 389-0038581-6/1/2
16AVT45 FROZEN VAC.PAC TUNA FILLETS(SAKU AA) LOT 1521
18-DEC-2007 FILTHY
LACKS N/C
P.T. Balinusa Windumas (Office)
Denpasar, Bali Bali, ID 1234 LOS-DO 389-0038581-6/1/5
16AVT45 FROZEN VAC.PAC TUNA FILLETS(GROUND MEAT) (P) LOT 1521
18-DEC-2007 HISTAMINE
Toshiba Consumer Products
Jawa Barat , ID 17550 FLA-DO TW2-0011855-6/1/1
94V--07 COLOR TV SETS
20-DEC-2007 NON STD
PT. Super Tuna Saku
Jakarta,Jakarta-Utara ID-NOTA, ID 14440 LOS-DO ASK-9911941-7/1/1A
16AGT45 FRZ TUNA FILLET SAKU (AA); cold storage lot #4870
27-DEC-2007 FILTHY
P.T. WIRA AKSARA
Jakarta ID-JK, ID 12430 LOS-DO 442-1997187-4/18/1
36AGT03 GULA JAWA ARENGA CANDY
27-DEC-2007 FILTHY
P.T. WIRA AKSARA
Jakarta ID-JK, ID 12430 LOS-DO 442-1997187-4/18/2
36AGT03 GULA JAWA ARENGA CANDY
27-DEC-2007 FILTHY
PT.DUA KELINCI
PATI ID-JT, ID 24567 LOS-DO 442-1986904-5/11/2
23BGT07 DK HOT COATED PEANUT
27-DEC-2007 UNSAFE COL
PT Ikafood Putramas
Bandung ID-JB, ID 5000 LOS-DO 442-1986904-5/13/11
28JCT99 SALTED SOYA-BEANS RELISH
27-DEC-2007 NEEDS FCE
NO PROCESS
Tunggal Jaya Prima
Medan ID-SU, ID 20362 LOS-DO 442-1971892-9/8/3
22KCY04 Sirsak Juice (Soupsop)
27-DEC-2007 LIST INGRE
NEEDS FCE
NO PROCESS
Pt. Ikaputera
Bandung , ID LOS-DO 442-0110479-9/12/9
27BCN99 KOKITA INDONESIAN SALAD DRESING(GADO GADO)
27-DEC-2007 NEEDS FCE
NO PROCESS
P.T. Sepatu Bata
Jakarta , ID LOS-DO 442-0107867-0/6/1
23BGB99 CANDLE NUT NAGA
27-DEC-2007 POISONOUS
Madsumaya Indo Seafood
Gresik , ID LOS-DO 385-0027377-6/1/3
16XGD21 FROZEN HEADLESS SHELL ON BLACK TIGER SHRIMP 8/12
27-DEC-2007 FILTHY
Madsumaya Indo Seafood
Gresik , ID LOS-DO 385-0027377-6/3/1
16XGD21 FROZEN HEADLESS SHELL ON BLACK TIGER SHRIMP 21/25
27-DEC-2007 FILTHY