FDA Inspection
Mannkind CorporationMannkind Corporation – FDA Inspection, Sep 7, 2018
Record Details
This FDA Inspection record concerns Mannkind Corporation, with an inspection on September 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6a902049-a3d3-4fa6-a3c0-f4f6f7c61200
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064802
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.52(e)(4)Date Received by Manufacturer
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.184(f)DHR - UDI not included
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Mannkind Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2024 | NAI | New England District Office | Postmarket Assurance: Medical Devices |
| May 15, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mannkind Corporation
- FDA Inspection 1250838 - 2024-10-03
- FDA Inspection 781626 - 2012-05-15
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