FDA Inspection 1076828 — Accriva Diagnostics, Inc.
The FDA completed an inspection of Accriva Diagnostics, Inc. on Jan 18, 2019 in San Diego, 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 18, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |