FDA Inspection 699854 — Avanos Medical, Inc.
The FDA completed an inspection of Avanos Medical, Inc. on November 19, 2010 in Alpharetta, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 19, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Alpharetta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |