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 |
|---|---|---|---|---|
| 109-0848756-3/1/1 | 03-Apr-2012 | 64ADY05 | 3007420666 | Sultan Healthcare |
| 109-0848756-3/2/1 | 03-Apr-2012 | 62FDR46 | 3007420666 | Sultan Healthcare |
| 109-0848756-3/8/1 | 03-Apr-2012 | 76LBH | 3007420666 | Sultan Healthcare |
| 109-0848756-3/8/2 | 03-Apr-2012 | 63RCQ04 | 3007420666 | Sultan Healthcare |
| 109-0848756-3/8/3 | 03-Apr-2012 | 63RCQ04 | 3007420666 | Sultan Healthcare |
| 109-0848756-3/8/4 | 03-Apr-2012 | 63RCQ04 | 3007420666 | Sultan Healthcare |
| 109-0848756-3/8/5 | 03-Apr-2012 | 63RCQ04 | 3007420666 | Sultan Healthcare |
| 234-0362468-9/1/1 | 03-Apr-2012 | 90LNH | 3009421290 | General Electric Ohio C |
| G32-0133040-1/1/1 | 03-Apr-2012 | 76EBF | 2024312 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical |
| G32-0133040-1/2/1 | 03-Apr-2012 | 76EBF | 2024312 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical |
| G32-0133040-1/3/1 | 03-Apr-2012 | 76EBF | 2024312 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical |
| G32-0133040-1/4/1 | 03-Apr-2012 | 76EBF | 3002105793 | Sybron Dental Specialties |
| G32-0133040-1/5/1 | 03-Apr-2012 | 76KLE | 3002105793 | Sybron Dental Specialties |
| 112-5595826-1/1/1 | 05-Apr-2012 | 54YCA99 | 2246912 | Vita Pure Inc |
| 112-6748757-2/1/1 | 06-Apr-2012 | 74DPS | 3009275215 | Cardiocore |
| 112-8271065-0/1/1 | 06-Apr-2012 | 62IQB99 | 3003563645 | Catalent Pharma Solutions, LLC |
| E7E-1026048-2/4/1 | 06-Apr-2012 | 61WBJ18 | 3009420795 | Actavis |
| E7E-1026048-2/4/4 | 06-Apr-2012 | 60LBL01 | 3004148087 | Qualitest Pharm Manuf |
| E7E-1026048-2/4/6 | 06-Apr-2012 | 61PDK58 | 3009291254 | Eli Lily |
| E7E-1026048-2/4/16 | 06-Apr-2012 | 66SDJ28 | 3008382249 | Savage Labs |
| E7E-1026048-2/4/17 | 06-Apr-2012 | 62ODK44 | 3005579246 | Hospira Inc. |
| E7E-1026048-2/4/18 | 06-Apr-2012 | 60QDK79 | 3005579246 | Hospira Inc. |
| E7E-1026048-2/4/2 | 06-Apr-2012 | 56ACA20 | 3005793212 | Sandoz Inc |
| E7E-1026048-2/4/5 | 06-Apr-2012 | 56IDA10 | 3003064821 | Abbott Laboratories |
| E7E-1026048-2/4/7 | 06-Apr-2012 | 62ODA39 | 3005793212 | Sandoz Inc |
| E7E-1026048-2/4/8 | 06-Apr-2012 | 60LAA05 | 3003913445 | Marley Pharmaceuticals |
| E7E-1026048-2/4/9 | 06-Apr-2012 | 61TDM17 | 2127022 | Paddock Laboratories, LLC |
| E7E-1026048-2/4/10 | 06-Apr-2012 | 62VDA30 | 3006778331 | Merck & Co Inc |
| E7E-1026048-2/4/11 | 06-Apr-2012 | 61KDL27 | 3003687826 | PBM Products, LLC |
| E7E-1026048-2/4/13 | 06-Apr-2012 | 60CCK04 | 3008196528 | Greenstone Llc |
| E7E-1026048-2/4/14 | 06-Apr-2012 | 61XDK18 | 1000162258 | Baxter International Inc |
| E7E-1026048-2/4/15 | 06-Apr-2012 | 61MDK11 | 3005579246 | Hospira Inc. |
| 112-6586517-5/1/1 | 09-Apr-2012 | 78FAJ | 3005791775 | Neotract Inc |
| WBG-0073428-8/1/1 | 09-Apr-2012 | 29BET11 | 3009478178 | Carolina Canners, Inc. |
| AEK-0275560-7/1/1 | 10-Apr-2012 | 90ITY | 1483239 | Dunlee |
| 112-5840123-6/1/1 | 10-Apr-2012 | 79GEI | 1000132435 | Stryker Sustainability Solutions, Inc. |
| 112-5840123-6/1/2 | 10-Apr-2012 | 74DRC | 1000132435 | Stryker Sustainability Solutions, Inc. |
| 112-5840123-6/1/3 | 10-Apr-2012 | 87HRX | 1000132435 | Stryker Sustainability Solutions, Inc. |
| UPS-5536009-6/1/1 | 11-Apr-2012 | 23HGT99 | 3009455503 | Cwi Packaging (West Coast) |
| FP1-0008127-1/1/1 | 13-Apr-2012 | 57VH02 | 3009450325 | Abaxis North America |
| BON-1003386-8/1/1 | 13-Apr-2012 | 79OYW | 3003462036 | Erchonia Corporation |
| CFX-9908429-2/1/1 | 16-Apr-2012 | 54ACK02 | 3009433575 | Apotheca Company |
| BUP-1538745-2/1/1 | 17-Apr-2012 | 74DPS | 2183461 | Mortara Instrument, Inc |
| ARE-4130527-2/1/1 | 19-Apr-2012 | 76EMA | 2515379 | Dentsply Caulk |
| ARE-4130527-2/2/1 | 19-Apr-2012 | 76EBF | 2515379 | Dentsply Caulk |
| ARE-4130527-2/3/1 | 19-Apr-2012 | 76EBF | 2515379 | Dentsply Caulk |
| UPS-5012036-5/1/1 | 20-Apr-2012 | 79GFE | 3008402475 | Nubrilliance |
| 551-9890342-4/2/1 | 20-Apr-2012 | 95RDW | 3003397726 | Kustom Signals Inc |
| 112-4013878-9/1/2 | 20-Apr-2012 | 68HCY10 | 2313380 | Schering Plough Animal Health Corp |
| 112-4540772-6/1/4 | 20-Apr-2012 | 54YBE99 | 2018618 | Pharmavite Corporation |
| 112-6778441-6/1/1 | 23-Apr-2012 | 62OCA10 | 1451914 | Abbott Laboratories |
| UPS-5479324-1/1/1 | 24-Apr-2012 | 87HXZ | 1719045 | Synthes (USA) |
| DU2-0013710-5/1/1 | 24-Apr-2012 | 79GAB | 3008517379 | Surgical Specialties |
| DU2-0013710-5/2/1 | 24-Apr-2012 | 79GAB | 3008517379 | Surgical Specialties |
| 112-6727369-1/1/1 | 25-Apr-2012 | 66FIA05 | 3009449447 | Metabolex Inc. |
| 178-1073184-8/1/1 | 25-Apr-2012 | 65PBE02 | 3009292230 | Ocvita Llc, |
| UPS-5933525-0/1/1 | 25-Apr-2012 | 54YCC99 | 2016045 | Northridge Laboratories Inc |
| F57-6124073-1/4/1 | 26-Apr-2012 | 66VAJ99 | 3005133042 | Englewood Lab, LLC |
| F57-6124073-1/6/1 | 26-Apr-2012 | 66PAJ99 | 3004979511 | Spaulding Service Center |
| F57-6124073-1/8/1 | 26-Apr-2012 | 66PAJ99 | 3004979511 | Spaulding Service Center |
| DM9-1200482-5/1/1/A | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/B | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/C | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/D | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/E | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/F | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/G | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/H | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/I | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/J | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/K | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/L | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/M | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/N | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| DM9-1200482-5/1/1/O | 26-Apr-2012 | 03UHT99 | 1418334 | Flavorchem |
| 112-6757065-8/1/1 | 30-Apr-2012 | 61NCB78 | 3008334958 | Pfizer |
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