FDA Inspection
Avanos Medical, Inc.Avanos Medical, Inc. – FDA Inspection, Jan 4, 2013
Record Details
This FDA Inspection record concerns Avanos Medical, Inc., with an inspection on January 4, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Avanos Medical, Inc.
- Inspection Date
- January 4, 2013
- Product Type
- Devices
View Company Profile
ID · 555de156-2d97-4299-a758-4aff8024f06d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 808748
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Avanos Medical, Inc.
18| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2025 | Not classified | Atlanta District Office | |
| December 15, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 14, 2018 | Not classified | Atlanta District Office | |
| October 2, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 13, 2018 | Not classified | Atlanta District Office |
Other documents for Avanos Medical, Inc.
- FDA Inspection 1239108 - 2025-02-28
- FDA Inspection 1225273 - 2023-12-15
- FDA Inspection 1102054 - 2018-11-14
- FDA Inspection 1067463 - 2018-10-02
- FDA Inspection 1123599 - 2018-09-13
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