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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for Indonesia


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
594-0225778-2/1/11 02-Jul-2012 16AGT45 3004255218 PT. Lautan Niaga Jaya
 
594-0225778-2/1/12 02-Jul-2012 16AGT45 3004255218 PT. Lautan Niaga Jaya
 
594-0225778-2/1/13 02-Jul-2012 16AGT45 3004255218 PT. Lautan Niaga Jaya
 
594-0225778-2/1/14 02-Jul-2012 16AGT45 3004255218 PT. Lautan Niaga Jaya
 
406-0476072-4/1/1 02-Jul-2012 16MGD09 3003196718 Pt. Kelola Mina Laut- Integrated Seafood Industries
 
406-0476072-4/1/2 02-Jul-2012 16MGD09 3003196718 Pt. Kelola Mina Laut- Integrated Seafood Industries
 
406-0476072-4/1/3 02-Jul-2012 16MGD09 3003196718 Pt. Kelola Mina Laut- Integrated Seafood Industries
 
112-7807608-3/3/1/O 03-Jul-2012 66VBY99 3006637730 Pt Reckitt Benckiser
 
112-7801862-2/6/1/A 06-Jul-2012 50NMY18 3003350259 Pt Mandom Indonesia Tbk
 
112-7801862-2/6/1/B 06-Jul-2012 50NMY18 3003350259 Pt Mandom Indonesia Tbk
 
112-8127040-0/1/1 06-Jul-2012 66BCS99 3009348564 UD Herba Asli
 
112-6059556-1/1/1 06-Jul-2012 54FDR99 3009348564 UD Herba Asli
 
97W-8800184-7/1/1 11-Jul-2012 16AVD45 3005887437 PT. Bali Mina Utama
 
555-0604698-0/1/1 12-Jul-2012 16MGD09 3004332629 PT. SULTRATUNA SAMUDRA
 
112-8261689-0/4/1/A 13-Jul-2012 53FH01 3003350259 Pt Mandom Indonesia Tbk
 
109-0857140-8/2/1 13-Jul-2012 66VCY99 3007691048 Johnson & Johnson Indonesia Pt
 
109-0857140-8/2/2 13-Jul-2012 66VCY99 3007691048 Johnson & Johnson Indonesia Pt
 
109-0857140-8/2/3 13-Jul-2012 66VCY99 3007691048 Johnson & Johnson Indonesia Pt
 
109-0857140-8/2/4 13-Jul-2012 66VCY99 3007691048 Johnson & Johnson Indonesia Pt
 
109-0857140-8/3/1 13-Jul-2012 66VCY99 3006848525 Reckitt Benckiser Indonesia
 
109-0857140-8/3/2 13-Jul-2012 66VCY99 3006848525 Reckitt Benckiser Indonesia
 
109-0857140-8/3/3 13-Jul-2012 66VCY99 3006848525 Reckitt Benckiser Indonesia
 
109-0857140-8/3/4 13-Jul-2012 66VCY99 3006848525 Reckitt Benckiser Indonesia
 
109-0857140-8/3/5 13-Jul-2012 66VCY99 3006848525 Reckitt Benckiser Indonesia
 
AQZ-0315017-7/1/1 18-Jul-2012 16AVT45 3004249162 Pt. Varia Niaga Nusantara
 
XXX-0178486-8/1/1 18-Jul-2012 54FDT99 3009348564 UD Herba Asli
 
EVJ-0116331-3/1/4 18-Jul-2012 16AGD45 2000045703 Pt. Hatindo Makmur
 
EVJ-0116331-3/1/5 18-Jul-2012 16AGD45 2000045703 Pt. Hatindo Makmur
 
EVJ-0116331-3/1/7 18-Jul-2012 16AGD45 2000045703 Pt. Hatindo Makmur
 
082-0329624-2/1/1 19-Jul-2012 16AGT45 3008300898 PT. STAR MARINDO
 
082-0329624-2/1/2 19-Jul-2012 16AGT45 3008300898 PT. STAR MARINDO
 
082-0329624-2/1/3 19-Jul-2012 16AGT45 3008300898 PT. STAR MARINDO
 
082-0329624-2/1/4 19-Jul-2012 16AGT45 3008300898 PT. STAR MARINDO
 
AEK-0377093-6/1/1/B 20-Jul-2012 98A06 3009599819 Pt Tresindo Asia Prima
 
HK1-0203171-1/1/1 20-Jul-2012 16AGT45 3008861400 PT Bandar Nelayan
 
HK1-0203171-1/1/3 20-Jul-2012 16AGT45 3008861400 PT Bandar Nelayan
 
HK1-0203171-1/1/4 20-Jul-2012 16AGT45 3008861400 PT Bandar Nelayan
 
101-9562045-4/1/1 24-Jul-2012 89NZF 3006681129 Esg Panatec
 
EVJ-0116498-0/1/2 24-Jul-2012 16AGD45 2000045703 Pt. Hatindo Makmur
 
EVJ-0116498-0/1/4 24-Jul-2012 16AGD45 2000045703 Pt. Hatindo Makmur
 
EVJ-0116498-0/1/5 24-Jul-2012 16AGD45 2000045703 Pt. Hatindo Makmur
 
EVJ-0116498-0/1/6 24-Jul-2012 16AGD45 2000045703 Pt. Hatindo Makmur
 
EVJ-0117272-8/1/3 24-Jul-2012 16AGD45 3005074782 PT Makmur Jaya Sejahtera
 
AEK-0222302-8/1/1 25-Jul-2012 54ABY99 3009558925 Broerry Soetarno
 
BEZ-0001922-2/1/1 25-Jul-2012 16XGN21 3004263266 PT Bumi Menara Internusa
 
BEZ-0001922-2/3/1 25-Jul-2012 16XGN21 3004263266 PT Bumi Menara Internusa
 
082-0329656-4/1/1/B 25-Jul-2012 16XGD21 3004285500 PT.Sumber Kalimantan Abadi
 
082-0329656-4/1/1/D 25-Jul-2012 16XGD21 3004285500 PT.Sumber Kalimantan Abadi
 
082-0329656-4/1/1/E 25-Jul-2012 16XGD21 3004285500 PT.Sumber Kalimantan Abadi
 
E4J-0007834-1/2/1 26-Jul-2012 16SVD45 3007946119 Pt Chen Woo Fishery
 
E4J-0007834-1/3/1 26-Jul-2012 16SVD45 3007946119 Pt Chen Woo Fishery
 
E4J-0007834-1/4/1 26-Jul-2012 16SVD45 3007946119 Pt Chen Woo Fishery
 
AEK-0336503-4/1/1 26-Jul-2012 54FYT95 3009490073 Faisal Putra Perdana
 
AEK-0338801-0/1/1 26-Jul-2012 54FCT99 3009490073 Faisal Putra Perdana
 
AEK-0338578-4/1/1 26-Jul-2012 54FYT99 3009490073 Faisal Putra Perdana
 
AEK-0338807-7/1/1 26-Jul-2012 54FCT99 3009490073 Faisal Putra Perdana
 
E4J-0007836-6/3/1 30-Jul-2012 16SVD45 3007946119 Pt Chen Woo Fishery
 
E4J-0007836-6/4/1 30-Jul-2012 16SVD45 3007946119 Pt Chen Woo Fishery
 
E4J-0007836-6/5/1 30-Jul-2012 16SVD45 3007946119 Pt Chen Woo Fishery
 
D52-9001519-2/4/1 30-Jul-2012 37KGT99 3004404337 PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
 
D52-9001519-2/4/4 31-Jul-2012 37KGT99 3004404337 PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
 
D52-9001519-2/4/5 31-Jul-2012 37KGT99 3004404337 PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY Tbk
 
112-4304659-1/1/1 31-Jul-2012 66BCS99 3009155249 Borneo Botanicals
 
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