1276436
Leesar Inc — FEI 3011513330
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 18, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fort Myers, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |