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. MAKMUR JAYA SEJAHTERA
JAKARTA ID-JK, ID 14440 ATL-DO ATK-4008333-0/1/2
16AGT45 FROZEN TUNA
04-MAR-2008 SALMONELLA
PT. MAKMUR JAYA SEJAHTERA
JAKARTA ID-JK, ID 14440 ATL-DO ATK-4008333-0/1/3
16AGT45 FROZEN TUNA
04-MAR-2008 SALMONELLA
PT. MAKMUR JAYA SEJAHTERA
JAKARTA ID-JK, ID 14440 ATL-DO ATK-4008333-0/1/4
16AGT45 FROZEN TUNA
04-MAR-2008 SALMONELLA
Pt Fajar Carawala
Jakarta , ID LOS-DO 555-0481168-2/1/1
16AVT45 FROZEN TUNA
04-MAR-2008 FILTHY
Pt Fajar Carawala
Jakarta , ID LOS-DO 555-0481168-2/1/2
16AVT45 FROZEN TUNA
04-MAR-2008 FILTHY
P. T. Intai Rainbow
Bali , ID SEA-DO 603-1078871-0/1/5
16AGT45 FROZEN YELLOWFIN STEAKS (CO TREATED) STEAKS 6OZ (IVP 1/10) (
Partial Refusal 05-MAR-2008 FILTHY
P. T. Intai Rainbow
Bali , ID SEA-DO 603-1078871-0/1/6
16AGT45 FROZEN YELLOWFIN STEAKS (CO TREATED) 6-8 OZ (IVP 1/10) (PLAI
Partial Refusal 05-MAR-2008 FILTHY
P. T. Intai Rainbow
Bali , ID SEA-DO 603-1078871-0/1/7
16AGT45 FROZEN YELLOWFIN STEAKS (CO TREATED) 4 OZ (TP 1/10) (CANNON
Partial Refusal 05-MAR-2008 FILTHY
P. T. Intai Rainbow
Bali , ID SEA-DO 603-1078871-0/1/8
16AGT45 FROZEN YELLOWFIN STEAKS (CO TREATED) POKE (1LB VP) (CANNON B
Partial Refusal 05-MAR-2008 FILTHY
Sterling Products
Jakarta , ID 14350 NOL-DO 112-0137960-2/1/1
60LBB01 854068830389 PANADOL and poldanmig (an NSAID)
10-MAR-2008 UNAPPROVED
Phillips Seafoods Indonesia-Medan Plant
Medan ID-NOTA, ID 20242 NYK-DO 112-0965195-2/1/2
16JEO01 Crab Specialty Backfin Meat
11-MAR-2008 FILTHY
Pt Aquafarm Nusantara Semarang
Semarang , ID 1234 NYK-DO G33-0151459-9/1/2
16XGD06 FROZEN TILAPIA FILLETS
12-MAR-2008 SALMONELLA
Toshiba Consumer Products
Jawa Barat , ID 17550 FLA-DO TW2-0012099-0/1/1
94V--07 COLOR TV SETS 13A26 / FOR EXPORT ONLY
14-MAR-2008 NO REGISTR
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO 595-4386771-3/1/1A
16AGT45 Frozen Yellowfin Tuna Steak 6 oz.
19-MAR-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO 595-4386771-3/1/1B
16AGT45 Frozen Yellowfin Tuna Steak 8 oz.
19-MAR-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO 595-4386771-3/1/1C
16AGT45 Frozen Yellowfin Tuna Steak 10 oz.
19-MAR-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO 595-4386771-3/1/1D
16AGT45 Frozen Yellowfin Tuna Steak 12 oz.
19-MAR-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO 595-4386771-3/1/1E
16AGT45 Frozen Yellowfin Tuna Loin 5/12
19-MAR-2008 FILTHY
Pt. Hatindo Makmur
Bali , ID 1234 LOS-DO 595-4386771-3/1/1F
16AGT45 Frozen Yellowfin Tuna Loin 12/up
19-MAR-2008 FILTHY
Unit Dua, Bumi Menara Internusa Pt
Suarabaya , ID LOS-DO 595-4383289-9/1/1
16JYD05 RAW VANNAMEI PEELED DEVEINED TAIL ON IQF
19-MAR-2008 SALMONELLA
PT Sepasang Naga Jaya
Jakarta Utara, ID 14410 LOS-DO 442-0138888-9/13/1
36AGT03 ARENGA SUGAR ROTARY
24-MAR-2008 FILTHY
PT Bali Maya Permai Food Canning Industry (Bali Factory)
Bali , ID LOS-DO ES2-0100273-1/2/1
16SGD42 FROZEN SWORDFISH STEAK, SIZE 6 OZ
24-MAR-2008 POISONOUS
PT Bali Maya Permai Food Canning Industry (Bali Factory)
Bali , ID LOS-DO ES2-0100273-1/2/2
16SGD42 FROZEN SWORDFISH STEAK, SIZE 8 OZ
24-MAR-2008 POISONOUS
PT Bali Maya Permai Food Canning Industry (Bali Factory)
Bali , ID LOS-DO ES2-0100273-1/2/3
16SGD42 FROZEN SWORDFISH STEAK, SIZE 10 OZ
24-MAR-2008 POISONOUS
Pt. Maja Agung Latexindo
Sumatra , ID SEA-DO WC4-4022455-6/2/1
80L--YY POWDERED LATEX EXAM GLOVES
28-MAR-2008 HOLES