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
P.T. Bonecom
Jakarta, Utara Utara, ID 14440 SAN-DO AQZ-0254090-7/1/3
16AVD37 FROZEN CO TREATED OPAKAPAKA FILLET NATURAL SIZE 4/6 OZ, VP
04-FEB-2008 SALMONELLA
P.T. Bonecom
Jakarta, Utara Utara, ID 14440 SAN-DO AQZ-0254090-7/1/4
16AVD37 FROZEN CO TREATED OPAKAPAKA FILLET NATURAL SIZE 6/8 OZ, VP
04-FEB-2008 SALMONELLA
P.T. Bonecom
Jakarta, Utara Utara, ID 14440 SAN-DO AQZ-0254090-7/1/5
16AVD37 FROZEN CO TREATED OPAKAPAKA FILLET NATURAL SIZE 8/10 OZ, VP
04-FEB-2008 SALMONELLA
P.T. Bonecom
Jakarta, Utara Utara, ID 14440 SAN-DO AQZ-0254090-7/1/6
16AVD37 FROZEN CO TREATED OPAKAPAKA FILLET NATURAL SIZE 10/12 OZ, VP
04-FEB-2008 SALMONELLA
P.T. Bonecom
Jakarta, Utara Utara, ID 14440 SAN-DO AQZ-0254090-7/1/7
16AVD37 FROZEN CO TREATED OPAKAPAKA FILLET NATURAL SIZE 12/16 OZ, VP
04-FEB-2008 SALMONELLA
P.T. Bonecom
Jakarta, Utara Utara, ID 14440 SAN-DO AQZ-0254090-7/1/8
16AVD37 FROZEN CO TREATED OPAKAPAKA FILLET PORTION SIZE 8/10 OZ, VP
04-FEB-2008 SALMONELLA
P.T. Bonecom
Jakarta, Utara Utara, ID 14440 SAN-DO AQZ-0254090-7/2/2
16AVD37 Crimson Snapper (Opakapaka) Individually Vacuum Packed 1.2-2
04-FEB-2008 FILTHY
Phan Kim Sheng
Jakarta , ID NOL-DO 112-1171758-5/1/1
54FBT99 854068882710 SUPP..
07-FEB-2008 LIST INGRE
LACKS FIRM
Pt. Ikaputera
Bandung , ID LOS-DO 442-0128580-4/1/3
28JCT99 Sambal Bajak COMBINATION CHILLI RELISH HOT
08-FEB-2008 NEEDS FCE
NO PROCESS
Pt. Indo American Seafoods
Tanjung , ID LOS-DO 082-0299541-4/1/1
16XGD21 FRZ. RAW SHELL ON SHRIMP U/5, 6/8, 8/12, 13/15
08-FEB-2008 FILTHY
Pt. Indo American Seafoods
Tanjung , ID LOS-DO 082-0299541-4/2/1
16XGD21 FRZ. RAW SHELL ON SHRIMP 16/20
08-FEB-2008 FILTHY
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 LOS-DO HK1-0173778-9/2/1
80L--YY LATEX EXAM GLOVES, POWDER FREE, SIZE: XS
12-FEB-2008 HOLES
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 LOS-DO HK1-0173778-9/2/2
80L--YY LATEX EXAM GLOVES, POWDER FREE, SIZE: S
12-FEB-2008 HOLES
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 LOS-DO HK1-0173778-9/2/3
80L--YY LATEX EXAM GLOVES, POWDER FREE, SIZE: M
12-FEB-2008 HOLES
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 LOS-DO HK1-0173778-9/2/4
80L--YY LATEX EXAM GLOVES, POWDER FREE, SIZE: L
12-FEB-2008 HOLES
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 LOS-DO HK1-0173778-9/2/5
80L--YY LATEX EXAM GLOVES, POWDER FREE, SIZE: XL
12-FEB-2008 HOLES
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 LOS-DO HK1-0173778-9/3/1
80L--YZ VINYL EXAM GLOVES, POWDER FREE, SIZE: M
12-FEB-2008 HOLES
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 LOS-DO HK1-0173778-9/3/2
80L--YZ VINYL EXAM GLOVES, POWDER FREE, SIZE: L
12-FEB-2008 HOLES
Super Saku Bali
Denpasar , ID LOS-DO 389-0038794-5/1/2
16AVT45 FROZEN VAC.PAC TUNA FILLETS(GROUND MEAT)
13-FEB-2008 HISTAMINE
PT Olam Indonesia
Bandar Lampung ID-LA, ID none NYK-DO EG6-1450318-3/1/1
28BHT54 BLACK PEPPER GROUND
14-FEB-2008 SALMONELLA
PT Olam Indonesia
Bandar Lampung ID-LA, ID none NYK-DO EG6-1451091-5/1/1
28BHT54 BLACK PEPPER GROUND
14-FEB-2008 SALMONELLA
PT Olam Indonesia
Bandar Lampung ID-LA, ID none NYK-DO EG6-1448464-0/14/1
28BHT54 BLACK PEPPER GROUND
14-FEB-2008 SALMONELLA
Toshiba Consumer Products
Jawa Barat , ID 17550 FLA-DO TW2-0011981-0/1/1
94V--07 COLOR TV SETS / FOR EXPORT ONLY
15-FEB-2008 NO REGISTR
Pt. Maja Agung Latexindo
Sumatra , ID PHI-DO 113-4214117-0/1/1
80L--YY LATEX EXAMINATION GLOVES ,POWDERED( ITEMS#A151302,A151303,A1
15-FEB-2008 HOLES
PT. Intimas Surya
Denpasar ID-BA, ID 80222 SEA-DO 603-1078439-6/1/1
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS SC-40Z IVP 1/10 (CANNO
Partial Refusal 20-FEB-2008 FILTHY
PT. Intimas Surya
Denpasar ID-BA, ID 80222 SEA-DO 603-1078439-6/1/2
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS 8OZ (IVP 1/10) (TRIDENT
20-FEB-2008 FILTHY
Pt. Mustika Minanusa Aurora
Tarakan, East Kalimantan , ID NYK-DO 385-2035121-4/1/1
16XGD21 FROZEN INDONESIAN HLSO BLACK TIGER SHRIMP 4/6
Partial Refusal 27-FEB-2008 SALMONELLA