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 |
|---|---|---|---|---|
| 417-0285367-6/2/1 | 04-Jan-2013 | 16XGN21 | 3006292147 | UNIT DUA, BUMI MENARA INTERNUSA, PT. |
| 417-0285367-6/2/5 | 04-Jan-2013 | 16XGN21 | 3006292147 | UNIT DUA, BUMI MENARA INTERNUSA, PT. |
| 417-0285367-6/2/6 | 04-Jan-2013 | 16XGN21 | 3006292147 | UNIT DUA, BUMI MENARA INTERNUSA, PT. |
| 417-0285367-6/2/8 | 04-Jan-2013 | 16XGN21 | 3006292147 | UNIT DUA, BUMI MENARA INTERNUSA, PT. |
| 417-0285367-6/2/2 | 04-Jan-2013 | 16XGN21 | 3006292147 | UNIT DUA, BUMI MENARA INTERNUSA, PT. |
| 417-0285367-6/2/3 | 04-Jan-2013 | 16XGN21 | 3006292147 | UNIT DUA, BUMI MENARA INTERNUSA, PT. |
| 417-0285367-6/2/4 | 04-Jan-2013 | 16XGN21 | 3006292147 | UNIT DUA, BUMI MENARA INTERNUSA, PT. |
| 417-0285367-6/2/7 | 04-Jan-2013 | 16XGN21 | 3006292147 | UNIT DUA, BUMI MENARA INTERNUSA, PT. |
| 417-0285367-6/2/9 | 04-Jan-2013 | 16XGN21 | 3006292147 | UNIT DUA, BUMI MENARA INTERNUSA, PT. |
| 417-0285367-6/2/10 | 04-Jan-2013 | 16XGN21 | 3006292147 | UNIT DUA, BUMI MENARA INTERNUSA, PT. |
| 417-0285367-6/2/11 | 04-Jan-2013 | 16XGN21 | 3006292147 | UNIT DUA, BUMI MENARA INTERNUSA, PT. |
| HK1-0204615-6/1/3 | 07-Jan-2013 | 16AGT45 | 3007584623 | PT Awindo International |
| HK1-0204615-6/1/1 | 07-Jan-2013 | 16AGT45 | 3007584623 | PT Awindo International |
| HK1-0204615-6/1/2 | 07-Jan-2013 | 16AGT45 | 3007584623 | PT Awindo International |
| HK1-0204615-6/1/4 | 07-Jan-2013 | 16AGT45 | 3007584623 | PT Awindo International |
| HK1-0204615-6/1/5 | 07-Jan-2013 | 16AGT45 | 3007584623 | PT Awindo International |
| HK1-0204615-6/1/6 | 07-Jan-2013 | 16AGT45 | 3007584623 | PT Awindo International |
| 316-1918454-7/1/1 | 11-Jan-2013 | 16AVT37 | 3005391503 | PT. MULTI SARI MAKASSAR |
| E4J-0009340-7/2/1 | 11-Jan-2013 | 16SVD37 | 3004250727 | PT CHEN WOO FISHERY |
| AEK-0546007-2/1/1 | 18-Jan-2013 | 54FIZ99 | 3009764484 | Reza Prasetyo W |
| AEK-0579148-4/1/1 | 22-Jan-2013 | 54EYY99 | 3009643007 | Mitra Alam Sejahtera |
| AEK-0645637-6/1/1 | 22-Jan-2013 | 98B06 | 3009599819 | Pt Tresindo Asia Prima |
| AEK-0579139-3/1/1 | 22-Jan-2013 | 54EYY99 | 3009558925 | Broerry Soetarno |
| AEK-0579141-9/1/1 | 22-Jan-2013 | 54EYY99 | 3009558925 | Broerry Soetarno |
| H67-1402795-9/1/1 | 23-Jan-2013 | 16AVT45 | 3007584623 | PT Awindo International |
| H67-1402795-9/2/1 | 23-Jan-2013 | 16AVT45 | 3007584623 | PT Awindo International |
| H67-1402795-9/3/1 | 23-Jan-2013 | 16AVT45 | 3007584623 | PT Awindo International |
| H67-1402795-9/4/1 | 23-Jan-2013 | 16AVT45 | 3007584623 | PT Awindo International |
| H67-1402795-9/5/1 | 23-Jan-2013 | 16AVT45 | 3007584623 | PT Awindo International |
| H67-1402795-9/6/1 | 23-Jan-2013 | 16AVT45 | 3007584623 | PT Awindo International |
| H67-1402795-9/7/1 | 23-Jan-2013 | 16AVT45 | 3007584623 | PT Awindo International |
| H67-1402795-9/8/1 | 23-Jan-2013 | 16AVT45 | 3007584623 | PT Awindo International |
| H67-1402795-9/9/1 | 23-Jan-2013 | 16AVT45 | 3007584623 | PT Awindo International |
| H67-1402795-9/11/1 | 23-Jan-2013 | 16AVT45 | 3007584623 | PT Awindo International |
| 406-0481566-8/1/1 | 29-Jan-2013 | 16AGD53 | 3004286185 | PT.Sabindo Raya Gemilang |
| 406-0481566-8/1/2 | 29-Jan-2013 | 16AGD53 | 3004286185 | PT.Sabindo Raya Gemilang |
| 112-4478182-4/1/1 | 29-Jan-2013 | 66BAY99 | 3008740316 | Rama Yogaswara |
| 112-4110784-1/1/1 | 29-Jan-2013 | 66BAY99 | 3008740316 | Rama Yogaswara |
| 594-0230536-7/1/1 | 31-Jan-2013 | 16AGT45 | 3004249162 | Pt. Varia Niaga Nusantara |
| 112-0090828-9/1/1 | 31-Jan-2013 | 66VBU99 | 3005157144 | PT Galenium Pharmasia Laboratories |
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