FDA Inspection 1131979 — Medtronic Heart Valves Division
The FDA completed an inspection of Medtronic Heart Valves Division on October 26, 2020 in Santa Ana, 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
- October 26, 2020
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Santa Ana, CA (United States)
Additional Details
Postmarket Audit Inspections
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 |