FDA Inspection 615770 — MicroVision, Inc.
The FDA completed an inspection of MicroVision, Inc. on September 29, 2009 in Seabrook, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Seabrook, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2403 | 21 CFR 820.25(a) | Sufficient personnel |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3218 | 21 CFR 820.70(c) | Environmental control system-documentation/review inspection |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |