Drug factory · FDA FEI 3001610451
Janssen Biotech, Inc.
200 Great Valley Pkwy, Malvern, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 29, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
13 drug inspections on record since 2008: 5 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amivantamab | Makes the active ingredient | Janssen Biotech, Inc. | 57894-501 |
| Amivantamab and Hyaluronidase (human Recombinant) | Makes 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) | Makes the active ingredient and tests it | Janssen Biotech, Inc. | 57894-503 |
| Guselkumab | Makes the active ingredient | 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 | Makes the active ingredient | Janssen Biotech, Inc. | 57894-800, 57894-801 |
| Siltuximab | Makes the active ingredient | Recordati Rare Diseases, Inc. | 73090-420, 73090-421 |
| Talquetamab | Makes the active ingredient | Janssen Biotech, Inc. | 57894-469, 57894-470 |
| Teclistamab | Makes the active ingredient | Janssen Biotech, Inc. | 57894-449, 57894-450 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 29, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 30, 2018 | No problems found | Bioresearch Monitoring | — |
| Mar 5, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 21, 2017 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| Feb 27, 2017 | No problems found | Bioresearch Monitoring | — |
| Aug 19, 2015 | No problems found | Bioresearch Monitoring | — |
| Sep 24, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 25, 2012 | No problems found | Bioresearch Monitoring | — |
| Jun 15, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 20, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 26, 2010 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| Aug 18, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 13, 2008 | No problems found | Bioresearch Monitoring | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 21, 2017 inspection
- Investigator non-compliance 21 CFR 312.56(b)
An investigator who did not comply with the signed agreement, the general investigational plan and applicable regulatory requirements was not promptly brought into compliance and terminated.
Oct 26, 2010 inspection
- General responsibilities of sponsors 21 CFR 312.50
Failure to ensure proper monitoring of the study.
Registered with FDA for: analysis; api manufacture; manufacture.