FDA Inspection
Avanos Medical, Inc.Avanos Medical, Inc. – FDA Inspection, Jul 8, 2011
Record Details
This FDA Inspection record concerns Avanos Medical, Inc., with an inspection on July 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Avanos Medical, Inc.
- Inspection Date
- July 8, 2011
- Product Type
- Devices
View Company Profile
ID · 4e99f7ac-dbdb-4434-ba9d-5dfd54ca62a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 734862
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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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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