FDA Inspection 1274527 — TRUMEDX LLC
The FDA completed an inspection of TRUMEDX LLC on June 26, 2025 in Shelton, CT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 26, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Shelton, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |