FDA Inspection 1284292 — G3 Medical
The FDA completed an inspection of G3 Medical on Sep 26, 2025 in Swannanoa, NC. 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
- Sep 26, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Swannanoa, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |