FDA Inspection 614960 — Vyaire Medical
The FDA completed an inspection of Vyaire Medical on Sep 18, 2009 in Minneapolis, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 18, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4189 | 21 CFR 820.198(a) | General |