1145642
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 7, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Northridge, CA (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 |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |