FDA Inspection 1268110 — Truemed Group LLC
The FDA completed an inspection of Truemed Group LLC on Apr 28, 2025 in The Woodlands, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 28, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- The Woodlands, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |