FDA Inspection 1198214 — Veran Medical Technologies Inc
The FDA completed an inspection of Veran Medical Technologies Inc on February 23, 2023 in Saint Louis, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 23, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |