FDA Inspection 814172 — Amedica Biotech, Inc.
The FDA completed an inspection of Amedica Biotech, Inc. on January 18, 2013 in Hayward, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 18, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hayward, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |