FDA Inspection 1325710 — Hospitec Usa
The FDA completed an inspection of Hospitec Usa on Jul 9, 2026 in Fort Smith, AR. 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
- Jul 9, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fort Smith, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |