Drug factory · FDA FEI 3002929455
Catalent CTS, LLC
10245 Hickman Mills Dr, Kansas City, MO, United States
No problems found at FDA's last inspection, Mar 4, 2022.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2010: 6 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cabozantinib | Makes it, tests it, packages it and labels it | Exelixis, Inc. | 42388-011, 42388-012, 42388-013 |
| Danicopan | Makes it, tests it, packages it and labels it | Catalent Pharma Solutions, LLC | 11014-0739 |
| Diclofenac | Makes it | Iroko Pharmaceuticals, LLC | 42211-203, 42211-204 |
| Duvelisib | Makes it and tests it | Secura Bio, Inc., Verastem, Inc. | 73116-215, 73116-225, 71779-115 +1 |
| Gemcitabine | Makes it, tests it and packages it | Janssen Biotech, Inc. | 57894-225 |
| Maribavir | Makes it, tests it, packages it and labels it | Takeda Pharmaceuticals America, Inc. | 64764-800 |
| Meloxicam | Makes it | Iroko Pharmaceuticals, LLC | 42211-205, 42211-206 |
| Sparsentan | Makes it | Travere Therapeutics, Inc. | 68974-200, 68974-400 |
| Zanubrutinib | Makes it and tests it | BeOne Medicines USA, Inc. | 72579-011 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 4, 2022 | No problems found | Drug Quality Assurance | — |
| Nov 6, 2017 | No problems found | Drug Quality Assurance | — |
| Jun 29, 2015 | No problems found | Drug Quality Assurance | — |
| Nov 10, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 5, 2014 | No problems found | Drug Quality Assurance | — |
| Jan 14, 2013 | No problems found | Drug Quality Assurance | — |
| Jun 8, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 24, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.