FDA Inspection 1095016 — Allwell Medical Corporation
The FDA completed an inspection of Allwell Medical Corporation on July 2, 2019 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
- July 2, 2019
- Fiscal Year
- 2019
- 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 |