FDA Inspection
Avanos Medical, Inc.Avanos Medical, Inc. – FDA Inspection, Sep 10, 2009
Record Details
This FDA Inspection record concerns Avanos Medical, Inc., with an inspection on September 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Avanos Medical, Inc.
- Inspection Date
- September 10, 2009
- Product Type
- Devices
View Company Profile
ID · 1afaafc5-a26f-4007-8c69-236f99ce0167
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 610664
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.70(a)(5)Criteria for workmanship
- 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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