1208059
Footprint Medical, Inc. — FEI 3007697249
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 14, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |