Celgene Corporation
FDA Regulatory Profile
Celgene Corporation has 0 FDA recalls, 23 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 18, 2025 · VAI
Part of the Bristol Myers Squibb corporate family.
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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 | 23 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 18, 2025 | Summit, NJ | Biologics | Voluntary Action Indicated (VAI) | 3004991673 |
| Dec 6, 2024 | Summit, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004991673 |
| Sep 6, 2024 | Summit, NJ | Drugs | No Action Indicated (NAI) | 3004991673 |
| Jan 31, 2024 | Summit, NJ | Drugs | No Action Indicated (NAI) | 3004991673 |
| Jun 16, 2023 | Summit, NJ | Biologics | Voluntary Action Indicated (VAI) | 3004991673 |
| Mar 14, 2022 | Summit, NJ | Drugs | No Action Indicated (NAI) | 3004991673 |
| Jun 3, 2020 | Summit, NJ | Drugs | No Action Indicated (NAI) | 3004991673 |
| Jul 26, 2019 | Summit, NJ | Biologics | No Action Indicated (NAI) | 3004991673 |
| Jun 27, 2018 | Summit, NJ | Drugs | No Action Indicated (NAI) | 3004991673 |
| Mar 17, 2017 | Summit, NJ | Drugs | No Action Indicated (NAI) | 3004991673 |
| Aug 4, 2015 | Berkeley Heights, NJ | Drugs | Voluntary Action Indicated (VAI) | 3009081543 |
| Apr 29, 2014 | Summit, NJ | Drugs | No Action Indicated (NAI) | 3004991673 |
| Apr 28, 2014 | Berkeley Heights, NJ | Drugs | No Action Indicated (NAI) | 3009081543 |
| Aug 7, 2013 | Warren, NJ | Drugs | No Action Indicated (NAI) | 3008931128 |
| Apr 24, 2013 | Berkeley Heights, NJ | Drugs | Voluntary Action Indicated (VAI) | 3009081543 |
| Sep 12, 2012 | Berkeley Heights, NJ | Drugs | Voluntary Action Indicated (VAI) | 3009081543 |
| Jul 30, 2012 | Summit, NJ | Drugs | No Action Indicated (NAI) | 3004991673 |
| May 3, 2012 | Overland Park, KS | Drugs | No Action Indicated (NAI) | 3003768152 |
| Aug 25, 2011 | Berkeley Heights, NJ | Drugs | Voluntary Action Indicated (VAI) | 3009081543 |
| Jun 17, 2011 | Summit, NJ | Drugs | No Action Indicated (NAI) | 3004991673 |
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.