FDA Inspection 986167 — Avanos Medical, Inc.
The FDA completed an inspection of Avanos Medical, Inc. on July 29, 2016 in Alpharetta, GA. 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 29, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Alpharetta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 648 | 21 CFR 803.18(e) | MDR not evaluated per 820.198 |