Catalent Maryland Inc
FDA Regulatory Profile
Catalent Maryland Inc has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Apr 9, 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 | 6 | 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 |
|---|
| Apr 9, 2025 | Baltimore, MD | Biologics | Voluntary Action Indicated (VAI) | 3015558590 |
| Nov 15, 2024 | Harmans, MD | Biologics | No Action Indicated (NAI) | 3015434301 |
| Mar 10, 2023 | Harmans, MD | Biologics | Voluntary Action Indicated (VAI) | 3015434301 |
| Jan 24, 2023 | Harmans, MD | Biologics | No Action Indicated (NAI) | 3015434301 |
| Nov 17, 2021 | Harmans, MD | Biologics | Voluntary Action Indicated (VAI) | 3015434301 |
| Nov 4, 2019 | Baltimore, MD | Biologics | Voluntary Action Indicated (VAI) | 3015558590 |
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.