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. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348580-3/2/1
21VFY04 GUAVA JUICE
04-JUN-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348580-3/3/1
21VFY19 LYCHEE JUICE
04-JUN-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348580-3/4/1
21VFY05 MANGO JUICE
04-JUN-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348580-3/5/1
22KFY04 SOURSOP JUICE
04-JUN-2008 JUICE %
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
Cv Makmur Pilar Mas
Jakarta , ID LOS-DO T81-4348580-3/16/1
36AGT99 PALM SUGAR
04-JUN-2008 FILTHY
NO ENGLISH
TRANSFAT
NUTRIT LBL
PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
BANDUNG Id-Jk, ID 40012 LOS-DO T81-4348580-3/25/1
31KYF20 TEH KOTAK Jasmine Tea
04-JUN-2008 TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
Pt. Gabungan Era Mandiri
Jakarta Indonesia , ID NWE-DO 530-0084003-2/1/1
16AGT51 FRZ SKINON/BNLS MAHI MAHI FLTS
05-JUN-2008 FILTHY
Ud. Damena
Pesanggaran Densapar Baali , ID NYK-DO H67-1312327-0/1/1
16AGD42 FROZEN SWORDFISH
06-JUN-2008 POISONOUS
PT. PANJI SABURAI PUTRA
Lampung Selatan , ID 35361 FLA-DO AMG-0070633-7/1/5
16JGO01 REFRIGERATED CANNED PASTEURIZED CRAB MEAT (SPECIAL)
09-JUN-2008 CHLORAMP
PT. PANJI SABURAI PUTRA
Lampung Selatan , ID 35361 FLA-DO AMG-0070633-7/1/1
16JGO01 REFRIGERATED CANNED PASTEURIZED CRAB MEAT (IMPERIAL)
10-JUN-2008 CHLORAMP
PT. PANJI SABURAI PUTRA
Lampung Selatan , ID 35361 FLA-DO AMG-0070633-7/1/2
16JGO01 REFRIGERATED CANNED PASTEURIZED CRAB MEAT (JUMBO LUMP)
10-JUN-2008 CHLORAMP
PT. PANJI SABURAI PUTRA
Lampung Selatan , ID 35361 FLA-DO AMG-0070633-7/1/3
16JGO01 REFRIGERATED CANNED PASTEURIZED CRAB MEAT (SUPER LUMP)
10-JUN-2008 CHLORAMP
PT. PANJI SABURAI PUTRA
Lampung Selatan , ID 35361 FLA-DO AMG-0070633-7/1/4
16JGO01 REFRIGERATED CANNED PASTEURIZED CRAB MEAT (REGULAR LUMP)
10-JUN-2008 CHLORAMP
PT. PANJI SABURAI PUTRA
Lampung Selatan , ID 35361 FLA-DO AMG-0070633-7/1/6
16JGO01 REFRIGERATED CANNED PASTEURIZED CRAB MEAT (CLAW MEAT)
10-JUN-2008 CHLORAMP
P.T. Super Saku Bali
DENPASAR ID-BA, ID 80223 LOS-DO 389-0039286-1/1/1
16AVT45 FROZEN VAC.PAC TUNA FILLETS(SAKU)
10-JUN-2008 FILTHY
Pt. Kemilau Bintang Timur
Makassar, Sulawesi ID-SN, ID 90241 NWE-DO EF1-0042858-2/1/1
16AFT37 FROZEN SNAPPER FILLETS
11-JUN-2008 FILTHY
Henchrist Gading Raya
Jakarta , ID LOS-DO 082-0301941-2/1/3
16AGT45 FROZEN TUNA STEAK SUPREME 6OZ,8OZ,
11-JUN-2008 FILTHY
PT HARAPAN BENDERANG
Surabaya Id-Su, ID NONE LOS-DO 082-0302566-6/1/2
16XGN21 FRZ. COOKED PEELED AND UNDEVEINED IQF SHRIMP SIZE 200/300; 3
12-JUN-2008 FILTHY
Rempah Rempah
Kuningan , ID NOL-DO 112-3056908-2/1/1
28YVT99 864127968036 VANILLA BEANS
16-JUN-2008 LACKS FIRM
LACKS N/C
USUAL NAME
P.T. Super Saku Bali
DENPASAR ID-BA, ID 80223 LOS-DO 389-0039243-2/1/4
16AVT45 FROZEN VAC.PAC TUNA FILLETS(GROUND MEAT) GM
17-JUN-2008 FILTHY
PT Central Windu Sejati Corporation
Surabaya , ID NYK-DO 594-0184759-1/1/1
16XGT21 FROZEN PDN SHRIMP
Partial Refusal 19-JUN-2008 SALMONELLA
Pt. Tegunsindo Lestaritama
Jakarta , ID SAN-DO 336-8737972-0/1/1
64IAH99 VENARIN DIETARY SUPPLEMENT
25-JUN-2008 NOT LISTED
UNAPPROVED
Pt. Embassy Seafood International
Jawa Barat , ID FLA-DO 826-0121235-8/1/1
16JEO01 PASTEURIZED CRABMEAT
26-JUN-2008 CHLORAMP
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 NWE-DO KM6-0107295-2/1/1
16AGT37 SCARLET SNAPPER FILLET SKIN ON BONELESS 4-6 OZ
27-JUN-2008 FILTHY
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 NWE-DO KM6-0107295-2/1/2
16AGT37 SCARLET SNAPPER FILLET SKIN ON BONELESS 6/8 OZ
27-JUN-2008 FILTHY
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 NWE-DO KM6-0107295-2/1/3
16AGT37 SCARLET SNAPPER FILLET SKIN ON BONELESS 8/10 OZ
27-JUN-2008 FILTHY
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 NWE-DO KM6-0107295-2/1/4
16AGT37 SCARLET SNAPPER FILLET SKIN ON BONELESS
27-JUN-2008 FILTHY
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 NWE-DO KM6-0107295-2/1/5
16AGT37 SCARLET SNAPPER NATURAL 4-6 OZ
27-JUN-2008 FILTHY
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 NWE-DO KM6-0107295-2/1/6
16AGT37 SCARLET SNAPPER NATURAL 6-8 OZ
27-JUN-2008 FILTHY
Arista Latindo Industrial, Ltd. P.T.
Jakarta Barat , ID 11210 NWE-DO KM6-0107295-2/1/7
16SGT37 SCARLET SNAPPER NATURAL 8-10 OZ
27-JUN-2008 FILTHY
Sumatra Pasak Bumi
Medan , ID NOL-DO 112-1383035-2/1/1
28NHT99 863365772537 HERBAL EXTRACT
30-JUN-2008 LIST INGRE
DIETARYLBL
LACKS FIRM
NUTRIT LBL
Pt Intimas Surya
Bali , ID SEA-DO 603-1080444-2/1/2
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS 8OZ IVP 1/10 (TRIDENT
30-JUN-2008 FILTHY
Pt Intimas Surya
Bali , ID SEA-DO 603-1080444-2/1/1
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS SC - 4OZ IVP 1/10 (TRID
30-JUN-2008 FILTHY
Pt Intimas Surya
Bali , ID SEA-DO 603-1080444-2/1/3
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS 6OZ IVP 1/10 (TRIDENT BO
30-JUN-2008 FILTHY
Pt Intimas Surya
Bali , ID SEA-DO 603-1080444-2/1/4
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS 4OZ IVP 1/30 (PLAIN BOX)
30-JUN-2008 FILTHY
Pt Intimas Surya
Bali , ID SEA-DO 603-1080444-2/1/5
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS SC-4 OZ IVP 1/10 (CANN
30-JUN-2008 FILTHY
PT. Intimas Surya
Denpasar ID-BA, ID 80222 SEA-DO 603-1080987-0/1/1
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS SC - 4OZ (IVP 1/10) (TRI
30-JUN-2008 FILTHY
PT. Intimas Surya
Denpasar ID-BA, ID 80222 SEA-DO 603-1080987-0/1/2
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS 8OZ (IVP 1/10) (TRIDENT
30-JUN-2008 FILTHY
PT. Intimas Surya
Denpasar ID-BA, ID 80222 SEA-DO 603-1080987-0/1/3
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS 6OZ (IVP 1/10) (TRIDENT
30-JUN-2008 FILTHY
PT. Intimas Surya
Denpasar ID-BA, ID 80222 SEA-DO 603-1080987-0/1/4
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS 4OZ (IVP 1/30) (PLAIN B
30-JUN-2008 FILTHY
PT. Intimas Surya
Denpasar ID-BA, ID 80222 SEA-DO 603-1080987-0/1/5
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS 6OZ (RETAIL) (IVP 1/30)
30-JUN-2008 FILTHY
PT. Intimas Surya
Denpasar ID-BA, ID 80222 SEA-DO 603-1080987-0/1/6
16AGT45 FROZEN YELLOWFIN STEAKS (VP) STEAKS SC - 4OZ (IVP 1/10) (CAN
30-JUN-2008 FILTHY
Pt. Ikafood Putramas
Bandung, Indonesia , ID LOS-DO 442-0147416-8/24/1
27BCI99 GADO GADO INDONESIAN SALAD DRESSING
30-JUN-2008 NEEDS FCE
NO PROCESS