Drug factory · FDA FEI 3002806632
Janssen Biologics B.V.
Einsteinweg101, Leiden, Netherlands
Problems found, fixed voluntarily at FDA's last inspection, Jun 1, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2010: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Amivantamab | Tests it |
Janssen Biotech, Inc. |
57894-501 |
| Amivantamab and Hyaluronidase (human Recombinant) | Tests it |
Janssen Biotech, Inc. |
57894-510, 57894-514, 57894-515 +1 |
| Ciltacabtagene Autoleucel | Tests it |
Janssen Biotech, Inc. |
57894-111 |
| Daratumumab | Tests it |
Janssen Biotech, Inc. |
57894-502, 57894-505 |
| Daratumumab and Hyaluronidase (human Recombinant) | Tests it |
Janssen Biotech, Inc. |
57894-503 |
| Golimumab | Makes the active ingredient and tests it |
Janssen Biotech, Inc. |
57894-070, 57894-071, 57894-350 |
| Guselkumab | Tests it |
Janssen Biotech, Inc. |
57894-640, 57894-650, 57894-651 |
| Infliximab | Makes the active ingredient and tests it |
Janssen Biotech, Inc. |
57894-030, 57894-160 |
| Nipocalimab | Tests it |
Janssen Biotech, Inc. |
57894-800, 57894-801 |
| Siltuximab | Tests it |
Recordati Rare Diseases, Inc. |
73090-420 |
| Talquetamab | Tests it |
Janssen Biotech, Inc. |
57894-469, 57894-470 |
| Teclistamab | Makes the active ingredient and tests it |
Janssen Biotech, Inc. |
57894-449, 57894-450 |
| Ustekinumab | Makes the active ingredient and tests it |
Janssen Biotech, Inc. |
57894-054, 57894-060, 57894-061 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Jun 1, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 11, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 15, 2018 | No problems found | Drug Quality Assurance | — |
| May 27, 2016 | No problems found | Drug Quality Assurance | — |
| Jul 11, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 28, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 6, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.