FDA Inspection 1052245 — Amtai Medical Equipment, INC
The FDA completed an inspection of Amtai Medical Equipment, INC on May 17, 2018 in Raleigh, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 17, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Raleigh, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |