Drug factory · FDA FEI 3000719749
Biogen MA Inc.
5000 Davis Drive, Morrisville, NC, United States
No problems found at FDA's last inspection, Jun 13, 2018.
No Action Indicated: inspectors found no objectionable conditions.
9 drug inspections on record since 2009: 6 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amivantamab | Makes the active ingredient and tests it | Janssen Biotech, Inc. | 57894-501 |
| Daratumumab | Makes the active ingredient | Janssen Biotech, Inc. | 57894-502 |
| Efanesoctocog Alfa | Makes the active ingredient | Bioverativ Therapeutics Inc. | 71104-978, 71104-979, 71104-981 +3 |
| Efmoroctocog Alfa | Makes the active ingredient and tests it | Bioverativ Therapeutics Inc. | 71104-801, 71104-802, 71104-803 +7 |
| Eftrenonacog Alfa | Makes the active ingredient and tests it | Bioverativ Therapeutics Inc. | 71104-911, 71104-922, 71104-933 +3 |
| Guselkumab | Makes the active ingredient | Janssen Biotech, Inc. | 57894-640, 57894-650, 57894-651 |
| Sutimlimab | Makes the active ingredient and tests it | Bioverativ Therapeutics Inc. | 80203-347 |
| Talquetamab | Makes the active ingredient and tests it | Janssen Biotech, Inc. | 57894-469, 57894-470 |
| Teclistamab | Makes the active ingredient and tests it | Janssen Biotech, Inc. | 57894-449, 57894-450 |
| Tocilizumab | Makes the active ingredient and tests it | Biogen MA Inc. | 64406-022, 64406-023 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 13, 2018 | No problems found | Drug Quality Assurance | — |
| Jan 15, 2016 | No problems found | Drug Quality Assurance | — |
| Jun 19, 2015 | No problems found | Drug Quality Assurance | — |
| Nov 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 2, 2013 | No problems found | Bioresearch Monitoring | — |
| Aug 2, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 30, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 25, 2009 | No problems found | Drug Quality Assurance | — |
| Jan 29, 2009 | No problems found | Bioresearch Monitoring | — |
Registered with FDA for: analysis; api manufacture.