FDA Inspection 880126 — SI-BONE, Inc.
The FDA completed an inspection of SI-BONE, Inc. on May 20, 2014 in Santa Clara, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 20, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Santa Clara, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |