FDA Inspection 1288408 — KSL Biomedical, Inc.
The FDA completed an inspection of KSL Biomedical, Inc. on October 24, 2025 in Buffalo, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 24, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: 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 |