FDA Inspection 1100095 — SonoCine Inc.
The FDA completed an inspection of SonoCine Inc. on August 16, 2019 in Reno, NV. 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
- August 16, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Reno, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14511 | 21 CFR 812.2(b) | Abbreviated requirements / non-significant risk study |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |