FDA Inspection 1107415 — Prestige Medical
The FDA completed an inspection of Prestige Medical on October 24, 2019 in Northridge, CA. 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
- October 24, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Northridge, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |