FDA Inspection 869745 — Avanos Medical, Inc.
The FDA completed an inspection of Avanos Medical, Inc. on March 7, 2014 in Alpharetta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 7, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Alpharetta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 740 | 21 CFR 803.52(a)(3) | Patient Gender |
| 763 | 21 CFR 803.52(c)(10) | Device Available for Evaluation |