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 |
|---|---|---|---|---|
| UPS-7367741-7/8/1 | 05-Sep-2012 | 76EFK | 2518040 | Integra York PA, Inc |
| UPS-7367741-7/8/2 | 05-Sep-2012 | 76EJY | 2518040 | Integra York PA, Inc |
| UPS-7367741-7/8/3 | 05-Sep-2012 | 79LRY | 2518040 | Integra York PA, Inc |
| 600-7287493-0/1/1 | 05-Sep-2012 | 90MOS | 3009511413 | Ge Medical |
| 600-7287493-0/1/2 | 05-Sep-2012 | 80LDQ | 3009511413 | Ge Medical |
| 600-7288789-0/1/1 | 05-Sep-2012 | 90MOS | 3000172423 | General Electric |
| UT4-0085444-4/1/1 | 06-Sep-2012 | 21GGH15 | 3001239055 | Wilbur Packing Co, Inc. |
| DE8-1201214-9/1/18 | 07-Sep-2012 | 53ED06 | 3005522062 | Matrix Essentials |
| 112-9109734-8/1/1 | 07-Sep-2012 | 74DQY | 3006646601 | Vascular Solutions |
| 112-2441278-8/1/1 | 11-Sep-2012 | 64BCK24 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/14 | 11-Sep-2012 | 56ICO10 | 3003782540 | E. Fougers & Co. |
| 112-2441278-8/1/18 | 11-Sep-2012 | 62FCO52 | 3004688211 | GlaxoSmithKline |
| 112-2441278-8/1/27 | 11-Sep-2012 | 66SCA27 | 3008938510 | Phizer Hosp Pdts Group |
| 112-2441278-8/1/32 | 11-Sep-2012 | 65QCA60 | 2431855 | Pliva Inc |
| 112-2441278-8/1/33 | 11-Sep-2012 | 61FCH30 | 3003092769 | Teva Pharmaceuticals USA |
| 112-2441278-8/1/37 | 11-Sep-2012 | 60WCA16 | 3003092769 | Teva Pharmaceuticals USA |
| 112-2441278-8/1/43 | 11-Sep-2012 | 60LCA01 | 3006461997 | Akyma Pharmaceuticals |
| 112-2441278-8/1/50 | 11-Sep-2012 | 62FCK17 | 1025121 | Vi-Jon, Inc. |
| 112-2441278-8/1/2 | 11-Sep-2012 | 64BCK24 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/16 | 11-Sep-2012 | 63ECK18 | 3002160581 | Fujisawa Health Care Inc |
| 112-2441278-8/1/22 | 11-Sep-2012 | 62OCA29 | 3002047518 | IVAX Pharmaceuticals |
| 112-2441278-8/1/25 | 11-Sep-2012 | 64CCK02 | 2127022 | Paddock Laboratories, LLC |
| 112-2441278-8/1/56 | 11-Sep-2012 | 61XCK18 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/57 | 11-Sep-2012 | 61TCK14 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/61 | 11-Sep-2012 | 60CCK04 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/63 | 11-Sep-2012 | 61XCK18 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/66 | 11-Sep-2012 | 60CCA57 | 1818658 | The Harvard Drug Group, LLC |
| 112-2441278-8/1/67 | 11-Sep-2012 | 60JCK02 | 3003433073 | Pharmatek |
| 112-2441278-8/1/3 | 11-Sep-2012 | 62CCH47 | 3003092769 | Teva Pharmaceuticals USA |
| 112-2441278-8/1/9 | 11-Sep-2012 | 61TCK17 | 1000429220 | Baxter Healthcare Corp |
| 112-2441278-8/1/19 | 11-Sep-2012 | 63FCK04 | 3007379904 | Glasko Wellcome |
| 112-2441278-8/1/21 | 11-Sep-2012 | 62GCK94 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/23 | 11-Sep-2012 | 60SCA06 | 3002047518 | IVAX Pharmaceuticals |
| 112-2441278-8/1/49 | 11-Sep-2012 | 56ACA20 | 3008938507 | Gsms |
| 112-2441278-8/1/62 | 11-Sep-2012 | 62OCK13 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/64 | 11-Sep-2012 | 62GCA41 | 3008938508 | Interpharm |
| 112-2441278-8/1/65 | 11-Sep-2012 | 61WCO18 | 1818658 | The Harvard Drug Group, LLC |
| 112-2441278-8/1/4 | 11-Sep-2012 | 61KCK62 | 1610287 | Alcon Research, Ltd. |
| 112-2441278-8/1/5 | 11-Sep-2012 | 61KCK62 | 1610287 | Alcon Research, Ltd. |
| 112-2441278-8/1/7 | 11-Sep-2012 | 64LCK37 | 1000113778 | Bausch & Lomb, Inc. |
| 112-2441278-8/1/15 | 11-Sep-2012 | 56ICO10 | 3003782540 | E. Fougers & Co. |
| 112-2441278-8/1/26 | 11-Sep-2012 | 63ICK01 | 2127022 | Paddock Laboratories, LLC |
| 112-2441278-8/1/28 | 11-Sep-2012 | 63WCK07 | 3002960808 | PURDUE Pharmaceuticals Lp |
| 112-2441278-8/1/41 | 11-Sep-2012 | 61NCO80 | 3008938512 | Wyeth Pharmaceuticals Company |
| 112-2441278-8/1/51 | 11-Sep-2012 | 65FIK99 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/54 | 11-Sep-2012 | 65RCK17 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/55 | 11-Sep-2012 | 60CCK04 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/6 | 11-Sep-2012 | 62LCO52 | 2024601 | Allergan |
| 112-2441278-8/1/8 | 11-Sep-2012 | 64LCK37 | 1000113778 | Bausch & Lomb, Inc. |
| 112-2441278-8/1/10 | 11-Sep-2012 | 61TCK17 | 1000429220 | Baxter Healthcare Corp |
| 112-2441278-8/1/12 | 11-Sep-2012 | 60CCY04 | 3008751485 | Dey Pharma |
| 112-2441278-8/1/17 | 11-Sep-2012 | 62LCA49 | 3008938506 | Geneva Pharmaceuticals Tech. |
| 112-2441278-8/1/20 | 11-Sep-2012 | 60CCK04 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/24 | 11-Sep-2012 | 64ADA04 | 3004758118 | Merch & Co Inc |
| 112-2441278-8/1/30 | 11-Sep-2012 | 60SCA04 | 1419642 | Rugby Laboratories, Inc. |
| 112-2441278-8/1/38 | 11-Sep-2012 | 56CCH73 | 3003092769 | Teva Pharmaceuticals USA |
| 112-2441278-8/1/47 | 11-Sep-2012 | 61NCA49 | 2450054 | Perrigo New York |
| 112-2441278-8/1/11 | 11-Sep-2012 | 61TCK17 | 3008938505 | Danbury Pharmacal |
| 112-2441278-8/1/13 | 11-Sep-2012 | 60CCA57 | 3005825045 | Ethex Corp |
| 112-2441278-8/1/29 | 11-Sep-2012 | 61TCA11 | 1419642 | Rugby Laboratories, Inc. |
| 112-2441278-8/1/31 | 11-Sep-2012 | 63BCQ27 | 1222021 | Sunovion Pharmaceuticals Inc. |
| 112-2441278-8/1/39 | 11-Sep-2012 | 64LCO28 | 3003092769 | Teva Pharmaceuticals USA |
| 112-2441278-8/1/52 | 11-Sep-2012 | 65FIK99 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/53 | 11-Sep-2012 | 65FIK99 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/58 | 11-Sep-2012 | 65FIK99 | 3005579246 | Hospira Inc. |
| 112-2441278-8/1/34 | 11-Sep-2012 | 62KCH08 | 3003092769 | Teva Pharmaceuticals USA |
| 112-2441278-8/1/35 | 11-Sep-2012 | 62LCA50 | 3003092769 | Teva Pharmaceuticals USA |
| 112-2441278-8/1/36 | 11-Sep-2012 | 61WCO47 | 3003092769 | Teva Pharmaceuticals USA |
| 112-2441278-8/1/42 | 11-Sep-2012 | 60QCK07 | 3006441852 | Abraxis Bioscience LLC |
| 112-2441278-8/1/44 | 11-Sep-2012 | 61KCK05 | 3002936358 | Amphastar Pharmaceuticals, Inc. |
| 112-2441278-8/1/48 | 11-Sep-2012 | 60QCO34 | 2450054 | Perrigo New York |
| 112-2441278-8/1/60 | 11-Sep-2012 | 64BCK24 | 3005579246 | Hospira Inc. |
| AEK-0437422-5/1/1 | 12-Sep-2012 | 86MVN | 2916547 | ABB CONCISE OPTICAL GROUP, LLC |
| 336-5456865-2/3/1 | 13-Sep-2012 | 53AC02 | 3007262486 | Burt's Bees Inc. |
| E8L-1016785-1/1/1 | 17-Sep-2012 | 53IH01 | 3009629136 | Franklin Botanical Laboratory Inc |
| BOS-0039167-5/1/1 | 18-Sep-2012 | 78FJK | 3001451489 | Fresenius Medical Care Holdings, Inc. |
| UPS-7182829-3/1/1 | 18-Sep-2012 | 54FYR99 | 3008615086 | IntegraCore, LLC |
| 322-0761112-4/2/1 | 21-Sep-2012 | 28BGH08 | 1122618 | Elite Spice Inc. |
| GEO-8500111-9/1/1 | 26-Sep-2012 | 66VCY99 | 1000132620 | Holland America Line - |
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