FDA Inspection 903196 — Vyaire Medical, Inc.
The FDA completed an inspection of Vyaire Medical, Inc. on Oct 31, 2014 in Palm Springs, CA. 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
- Oct 31, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Palm Springs, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4252 | 21 CFR 821.25(c)(3) | Quality assurance procedures: 6-month & annual audits |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 745 | 21 CFR 803.52(b)(2) | Death |
| 760 | 21 CFR 803.52(c)(4) | Device Identification Information |