FDA Inspection 1092774 — Truemed Group LLC
The FDA completed an inspection of Truemed Group LLC on Jun 5, 2019 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 5, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- The Woodlands, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |