Catalent Ontario Limited
FDA Regulatory Profile
Catalent Ontario Limited has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- May 2, 2025 · VAI
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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 | 11 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| May 2, 2025 | Strathroy, Canada | Veterinary | Voluntary Action Indicated (VAI) | 3007325436 |
| Jan 20, 2023 | Windsor, Canada | Drugs | Voluntary Action Indicated (VAI) | 3000118564 |
| Apr 12, 2019 | Strathroy, Canada | Drugs | Voluntary Action Indicated (VAI) | 3007325436 |
| Feb 8, 2019 | Windsor, Canada | Drugs | Voluntary Action Indicated (VAI) | 3000118564 |
| Jun 29, 2018 | Windsor, Canada | Drugs | Official Action Indicated (OAI) | 3000118564 |
| Sep 18, 2015 | Windsor, Canada | Drugs | No Action Indicated (NAI) | 3000118564 |
| Nov 7, 2014 | Strathroy, Canada | Drugs | No Action Indicated (NAI) | 3007325436 |
| Sep 6, 2013 | Windsor, Canada | Drugs | No Action Indicated (NAI) | 3000118564 |
| Sep 21, 2011 | Strathroy, Canada | Drugs | No Action Indicated (NAI) | 3007325436 |
| Sep 16, 2011 | Windsor, Canada | Drugs | Voluntary Action Indicated (VAI) | 3000118564 |
| Aug 14, 2009 | Windsor, Canada | Drugs | No Action Indicated (NAI) | 3000118564 |
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.