FDA Inspection 1272617 — Ion Medical, Inc.
The FDA completed an inspection of Ion Medical, Inc. on Jun 13, 2025 in Jacksonville, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 13, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |