Warning letter
Catalent Indiana, LLC: warning letter of Nov 20, 2025
FDA warning letter 718189 · Office of Manufacturing Quality
Key facts
| Reference number | 718189 |
|---|---|
| Company | Catalent Indiana, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Nov 20, 2025 |
| Posted date | Dec 11, 2025 |
| Issuing office | Office of Manufacturing Quality |
| Product type | Drugs |
| CFR sections cited | 211.113(b), 211.192 |
| Inspection city | Bloomington |
| Inspection ZIP | 47403 |
| Inspection start date | Jun 23, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: