MannKind Corporation
MannKind Corporation has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Nov 4, 2025 · NAI
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Summary
| 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 | 8 | Nov 9, 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 |
|---|---|---|---|---|
| Nov 4, 2025 | Danbury, CT | Drugs | No Action Indicated (NAI) | 3005340341 |
| Oct 3, 2024 | Marlborough, MA | Devices | Voluntary Action Indicated (VAI) | 3003154078 |
| Aug 6, 2021 | Danbury, CT | Drugs | Voluntary Action Indicated (VAI) | 3005340341 |
| Sep 7, 2018 | Marlborough, MA | Devices | Voluntary Action Indicated (VAI) | 3003154078 |
| Jun 19, 2018 | Danbury, CT | Devices | No Action Indicated (NAI) | 3005340341 |
| May 17, 2013 | Danbury, CT | Drugs | Voluntary Action Indicated (VAI) | 3005340341 |
| May 15, 2012 | Marlborough, MA | Devices | No Action Indicated (NAI) | 3003154078 |
| Dec 4, 2009 | Danbury, CT | Drugs | Voluntary Action Indicated (VAI) | 3005340341 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3005340341 | Danbury, CT | 5 | Nov 4, 2025 |
| FEI 3003154078 | Marlborough, MA | 3 | Oct 3, 2024 |