Drug factory · FDA FEI 3002806695
Cilag AG
Hochstrasse 201, Schaffhausen, Switzerland
No problems found at FDA's last inspection, Nov 21, 2025.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2009: 3 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Amivantamab | Makes it, tests it, packages it and labels it |
Janssen Biotech, Inc. |
57894-501 |
| Amivantamab and Hyaluronidase (human Recombinant) | Makes it, tests it, packages it and labels it |
Janssen Biotech, Inc. |
57894-510, 57894-514, 57894-515 +1 |
| Bedaquiline | Makes the active ingredient |
Janssen Products LP |
59676-701, 59676-702 |
| Cobicistat and Darunavir | Makes the active ingredient |
Janssen Products LP |
59676-575 |
| Daratumumab | Makes it, tests it, packages it and labels it |
Janssen Biotech, Inc. |
57894-502, 57894-505 |
| Daratumumab and Hyaluronidase (human Recombinant) | Makes it, tests it, packages it and labels it |
Janssen Biotech, Inc. |
57894-503 |
| Darunavir | Makes the active ingredient |
Janssen Products LP |
59676-562, 59676-563, 59676-564 +2 |
| Erdafitinib | Makes the active ingredient |
Janssen Products LP |
59676-030, 59676-040, 59676-050 |
| Golimumab | Makes it, tests it, packages it and labels it |
Janssen Biotech, Inc. |
57894-070, 57894-071, 57894-350 |
| Guselkumab | Makes it, tests it, packages it and labels it |
Janssen Biotech, Inc. |
57894-640, 57894-650, 57894-651 |
| Infliximab | Makes it, tests it and packages it |
Janssen Biotech, Inc. |
57894-030, 57894-160 |
| Nipocalimab | Tests it and packages it |
Janssen Biotech, Inc. |
57894-800, 57894-801 |
| Peramivir | Makes the active ingredient and tests it |
BioCryst Pharmaceuticals, Inc., Seqirus USA Inc. |
72769-181, 61364-181 |
| Risperidone | Makes it and packages it |
Janssen Pharmaceuticals, Inc. |
50458-306, 50458-307, 50458-308 +1 |
| Siltuximab | Makes it |
Recordati Rare Diseases, Inc. |
73090-420, 73090-421 |
| Talquetamab | Tests it |
Janssen Biotech, Inc. |
57894-469, 57894-470 |
| Teclistamab | Tests it |
Janssen Biotech, Inc. |
57894-449, 57894-450 |
| Topiramate | Makes the active ingredient |
Janssen Pharmaceuticals, Inc. |
50458-639, 50458-640, 50458-641 +3 |
| Ustekinumab | Makes it and tests it |
Janssen Biotech, Inc. |
57894-054, 57894-060, 57894-061 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Nov 21, 2025 | No problems found | Drug Quality Assurance | — |
| May 5, 2023 | No problems found | Drug Quality Assurance | — |
| Jul 16, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 8, 2015 | No problems found | Drug Quality Assurance | — |
| Feb 18, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 27, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 3, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 15, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.