FDA Inspection 1256165 — Amtai Medical Equipment, INC
The FDA completed an inspection of Amtai Medical Equipment, INC on December 6, 2024 in Raleigh, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 6, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Raleigh, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |