FDA Inspection
Mannkind CorporationMannkind Corporation – FDA Inspection, Oct 3, 2024
Record Details
This FDA Inspection record concerns Mannkind Corporation, with an inspection on October 3, 2024, issued by the New England District Office, covering medical devices & rad health.
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ID · 84d9c0c9-a0a3-4c10-a79e-d4dc764bc005
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1250838
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Mannkind Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 15, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mannkind Corporation
- FDA Inspection 1064802 - 2018-09-07
- FDA Inspection 781626 - 2012-05-15
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