1288408
KSL Biomedical, Inc. — FEI 3017505309
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 24, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Buffalo, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |