Catalent Pharma Solutions, LLC
FDA Regulatory Profile
Catalent Pharma Solutions, LLC has 0 FDA recalls, 40 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- May 22, 2026 · 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 | 40 | 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 22, 2026 | Morrisville, NC | Drugs | Voluntary Action Indicated (VAI) | 1000110912 |
| Jan 30, 2026 | Saint Petersburg, FL | Drugs | Voluntary Action Indicated (VAI) | 1811396 |
| Dec 17, 2025 | Philadelphia, PA | Biologics | No Action Indicated (NAI) | 3007617094 |
| Jun 5, 2025 | Philadelphia, PA | Drugs | No Action Indicated (NAI) | 3007617094 |
| Apr 22, 2025 | Winchester, KY | Drugs | Voluntary Action Indicated (VAI) | 1000122400 |
| May 30, 2024 | Saint Petersburg, FL | Drugs | No Action Indicated (NAI) | 1811396 |
| May 24, 2024 | Morrisville, NC | Biologics | Voluntary Action Indicated (VAI) | 1000110912 |
| Jan 25, 2024 | Saint Petersburg, FL | Devices | No Action Indicated (NAI) | 1811396 |
| Jul 21, 2023 | Saint Petersburg, FL | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1811396 |
| Jan 11, 2023 | Winchester, KY | Drugs | Voluntary Action Indicated (VAI) | 1000122400 |
| Dec 15, 2022 | Morrisville, NC | Drugs | Voluntary Action Indicated (VAI) | 1000110912 |
| Sep 28, 2020 | Morrisville, NC | Drugs | Official Action Indicated (OAI) | 1000110912 |
| Dec 20, 2019 | Morrisville, NC | Drugs | No Action Indicated (NAI) | 1000110912 |
| Aug 28, 2019 | Saint Petersburg, FL | Devices | Voluntary Action Indicated (VAI) | 1811396 |
| Apr 16, 2019 | Philadelphia, PA | Drugs | No Action Indicated (NAI) | 3007617094 |
| Mar 4, 2019 | Morrisville, NC | Veterinary | No Action Indicated (NAI) | 1000110912 |
| Feb 22, 2019 | Saint Petersburg, FL | Drugs | Voluntary Action Indicated (VAI) | 1811396 |
| Feb 1, 2019 | Morrisville, NC | Drugs | No Action Indicated (NAI) | 1000110912 |
| Jun 14, 2018 | Saint Petersburg, FL | Drugs | Voluntary Action Indicated (VAI) | 1811396 |
| Nov 15, 2017 | Winchester, KY | Drugs | No Action Indicated (NAI) | 1000122400 |
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 1000110912 | Morrisville, NC | 12 | May 22, 2026 |
| FEI 1811396 | Saint Petersburg, FL | 12 | Jan 30, 2026 |
| FEI 3007617094 | Philadelphia, PA | 4 | Dec 17, 2025 |
| FEI 1000122400 | Winchester, KY | 10 | Apr 22, 2025 |
| FEI 2245314 | Allendale, NJ | 1 | Oct 4, 2011 |
| FEI 3002816657 | San Diego, CA | 1 | Nov 16, 2009 |