1064802
Mannkind Corporation — FEI 3003154078
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 7, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Marlborough, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 774 | 21 CFR 803.52(e)(4) | Date Received by Manufacturer |