Drug factory · FDA FEI 3005949964
Catalent Indiana, LLC
1300 S. Patterson Drive, Bloomington, IN, United States
Serious problems, FDA action at FDA's last inspection, Apr 24, 2026.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
10 drug inspections on record since 2013: 2 with no problems, 6 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aflibercept | Makes it | Regeneron Pharmaceuticals, Inc. | 61755-005 |
| Cemiplimab | Makes it and tests it | Regeneron Pharmaceuticals, Inc. | 61755-008 |
| Daratumumab and Hyaluronidase (human Recombinant) | Makes the active ingredient | Janssen Biotech, Inc. | 57894-503 |
| Efgartigimod Alfa and Hyaluronidase (human Recombinant) | Makes the active ingredient | argenx US | 73475-1221, 73475-3102 |
| Glatiramer | Makes it and tests it | Caraco Pharmaceutical Laboratories, Ltd. | 47335-990, 47335-991 |
| Human Immunoglobulin G and Hyaluronidase (human Recombinant) | Makes the active ingredient | Takeda Pharmaceuticals America, Inc. | 0944-2510, 0944-2511, 0944-2512 +2 |
| Thrombin Alfa | Makes it and tests it | The Medicines Company | 65293-006, 65293-007 |
| Tralokinumab | Makes it, tests it, packages it and labels it | LEO Pharma Inc. | 50222-346, 50222-350 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 24, 2026 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jul 14, 2025 | Serious problems, FDA action | Drug Quality Assurance | — |
| Nov 15, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 1, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 19, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 19, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 7, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 25, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 17, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.