FDA Inspection 698004 — Baxano, Inc.
The FDA completed an inspection of Baxano, Inc. on November 30, 2010 in San Jose, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 30, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |