Import Refusal Report
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Refusal Actions by FDA as Recorded in OASIS
for United States
| Entry/doc/line/sfx | Refusal Date | Product Code |
Manufacturer FEI |
Manufacturer Name |
|---|---|---|---|---|
| 112-7346363-8/1/1 | 01-Jul-2005 | 86HQZ | 3000204253 | Elite Optik US, LP |
| AEK-6669322-3/1/1 | 06-Jul-2005 | 64RBE18 | 3003519524 | Technipak |
| 406-0367713-5/1/1 | 11-Jul-2005 | 94V07 | 3004193831 | Panasonic Avc Networks Company America |
| 406-0367713-5/2/1 | 11-Jul-2005 | 94V07 | 3004193831 | Panasonic Avc Networks Company America |
| 112-7314611-8/1/1 | 11-Jul-2005 | 77ETC | 3002111873 | Starkey Laboratories Inc |
| 112-7314611-8/1/2 | 11-Jul-2005 | 77KHL | 3002111873 | Starkey Laboratories Inc |
| 110-1494324-9/1/1 | 11-Jul-2005 | 85MCN | 3004474407 | Fziomed Inc |
| 110-1494087-2/1/1 | 11-Jul-2005 | 85MCN | 3004474407 | Fziomed Inc |
| 110-1494803-2/1/1 | 11-Jul-2005 | 85MCN | 3004474407 | Fziomed Inc |
| 112-7573441-6/1/1 | 12-Jul-2005 | 86HMX | 1000135560 | American Optisurgical Inc |
| 112-7487252-2/1/1 | 13-Jul-2005 | 86MVN | 3002340631 | Art Optical Contact Lens, Inc. |
| 110-1167055-5/1/1 | 18-Jul-2005 | 54YYY99 | 3004031138 | Nilen Alliance Group |
| 112-6929411-2/1/1 | 18-Jul-2005 | 64LAY37 | 3005117803 | Ganeden Biotech |
| 112-6929411-2/1/2 | 18-Jul-2005 | 62CAY41 | 3005117803 | Ganeden Biotech |
| 112-6929411-2/2/1 | 18-Jul-2005 | 55RP32 | 3005117803 | Ganeden Biotech |
| 112-6929411-2/3/1 | 18-Jul-2005 | 57YY99 | 3005117803 | Ganeden Biotech |
| 112-6955941-5/1/1 | 18-Jul-2005 | 55RP55 | 2210396 | Novartis Pharmaceuticals Corp. |
| 112-7017874-2/1/1 | 19-Jul-2005 | 79LRR | 3005128996 | Sgr Fbo |
| 112-7032682-0/1/1 | 19-Jul-2005 | 78MRE | 3004457970 | Sanofi-Synthelabo Inc |
| 112-7448218-1/1/1 | 19-Jul-2005 | 73BYG | 3004905470 | In Eros Corporation |
| 112-7226742-8/1/1 | 19-Jul-2005 | 86HQY | 3000206798 | Spy Optic Inc |
| AEK-6596709-9/1/1 | 20-Jul-2005 | 77ESD | 3005235392 | E Wellman |
| 004-9719400-1/1/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/2/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/3/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/4/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/5/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/6/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/7/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/8/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/9/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/10/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/11/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/12/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/13/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/14/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/15/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/16/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/17/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 004-9719400-1/18/1 | 20-Jul-2005 | 74MIH | 1000442125 | Medtronic Inc |
| 112-7033174-7/6/1 | 20-Jul-2005 | 64UCY06 | 3004758118 | Merch & Co Inc |
| 112-7060617-1/1/1 | 21-Jul-2005 | 74DPS | 3003225067 | Research Tech |
| 406-0368558-3/1/1 | 21-Jul-2005 | 94V07 | 3004193831 | Panasonic Avc Networks Company America |
| 112-7110269-1/1/1 | 21-Jul-2005 | 95L22 | 3005142964 | Beam Of Light Technologies Inc |
| 300-2584490-0/1/1 | 22-Jul-2005 | 55QY12 | 2410528 | Watson Foods Co., Inc. |
| 300-2643483-4/1/1 | 22-Jul-2005 | 55QY12 | 2410528 | Watson Foods Co., Inc. |
| 112-7211967-8/1/1 | 22-Jul-2005 | 77KHL | 3004080549 | University of Miami School of Medicine Immune Monitoring Lab |
| 112-7226900-2/1/1 | 22-Jul-2005 | 86HQY | 3005158019 | Dorfman Gila |
| 112-7246347-2/1/1 | 22-Jul-2005 | 62LIB44 | 3004383917 | Glakosmithcline |
| 336-3020641-8/1/1/A | 23-Jul-2005 | 66VBA99 | 3004983426 | PurQuality, LLC |
| 336-3020641-8/1/1/B | 23-Jul-2005 | 66VBB99 | 3004983426 | PurQuality, LLC |
| 336-3020641-8/1/1/C | 23-Jul-2005 | 66VBC99 | 3004983426 | PurQuality, LLC |
| 336-3020641-8/1/1/D | 23-Jul-2005 | 66VBC99 | 3004983426 | PurQuality, LLC |
| 112-7301563-6/1/1 | 25-Jul-2005 | 61WCP52 | 2210396 | Novartis Pharmaceuticals Corp. |
| 112-7410948-7/1/1 | 25-Jul-2005 | 79KGZ | 3003850488 | Carimedix |
| 406-0367828-1/1/1 | 26-Jul-2005 | 94V07 | 3004193831 | Panasonic Avc Networks Company America |
| 406-0367828-1/2/1 | 26-Jul-2005 | 94V07 | 3004193831 | Panasonic Avc Networks Company America |
| 112-7345658-2/1/1 | 26-Jul-2005 | 89MOZ | 1000472454 | Medicis Pharmaceutical Corp |
| 112-7504272-9/1/1 | 26-Jul-2005 | 86HQY | 3002303111 | Carrera Sport |
| BGK-0024076-3/107/1 | 28-Jul-2005 | 66PBY99 | 3003831761 | Jason Natural Products |
| 510-7572519-5/1/1 | 28-Jul-2005 | 74LIT | 3003524171 | Avantec Vascular Corporation |
| BGK-0024048-2/5/1 | 28-Jul-2005 | 60QAO56 | 3001332624 | Pipedream Products Inc. |
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