Catalent Indiana, LLC
FDA Regulatory Profile
Catalent Indiana, LLC has 0 FDA recalls, 13 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Apr 24, 2026 · OAI
Reviewing Catalent Indiana, LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Check this supplier
Or check Catalent Indiana, LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 13 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Apr 24, 2026 | Bloomington, IN | Drugs | Official Action Indicated (OAI) | 3005949964 |
| Jul 14, 2025 | Bloomington, IN | Drugs | Official Action Indicated (OAI) | 3005949964 |
| Nov 15, 2023 | Bloomington, IN | Biologics | Voluntary Action Indicated (VAI) | 3005949964 |
| Sep 1, 2022 | Bloomington, IN | Drugs | Voluntary Action Indicated (VAI) | 3005949964 |
| Oct 18, 2019 | Bloomington, IN | Drugs | Voluntary Action Indicated (VAI) | 3005949964 |
| Aug 3, 2018 | Bloomington, IN | Biologics | No Action Indicated (NAI) | 3005949964 |
| Jan 19, 2018 | Bloomington, IN | Drugs | Voluntary Action Indicated (VAI) | 3005949964 |
| May 19, 2017 | Bloomington, IN | Drugs | Voluntary Action Indicated (VAI) | 3005949964 |
| Aug 24, 2016 | Bloomington, IN | Biologics | Voluntary Action Indicated (VAI) | 3005949964 |
| Nov 7, 2014 | Bloomington, IN | Drugs | No Action Indicated (NAI) | 3005949964 |
| Oct 25, 2013 | Bloomington, IN | Drugs | Voluntary Action Indicated (VAI) | 3005949964 |
| Jun 17, 2013 | Bloomington, IN | Drugs | No Action Indicated (NAI) | 3005949964 |
| Dec 15, 2011 | Bloomington, IN | Devices | No Action Indicated (NAI) | 3005949964 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3005949964 | Bloomington, IN | 13 | Apr 24, 2026 |