FDA Inspection 607226 — Mission Systems Davenport Inc.
The FDA completed an inspection of Mission Systems Davenport Inc. on August 12, 2009 in Davenport, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 12, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Davenport, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |