FDA Inspection 551423 — Medtronic Heart Valves Division
The FDA completed an inspection of Medtronic Heart Valves Division on December 19, 2008 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 19, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Santa Ana, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |