FDA Inspection 1092774 — Truemed Group LLC
The FDA completed an inspection of Truemed Group LLC on June 5, 2019 in The Woodlands, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 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 |