FDA Inspection 656861 — Piezosurgery Inc
The FDA completed an inspection of Piezosurgery Inc on April 12, 2010 in Hilliard, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 12, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hilliard, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3837 | 21 CFR 820.25(b) | Training records |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |