1155998
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 4, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dana Point, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |