FDA Inspection
Avanos Medical, Inc.Avanos Medical, Inc. – FDA Inspection, Oct 31, 2012
Record Details
This FDA Inspection record concerns Avanos Medical, Inc., with an inspection on October 31, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Avanos Medical, Inc.
- Inspection Date
- October 31, 2012
- Product Type
- Devices
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ID · deee3abc-c43b-4000-8551-897cc4a1ea14
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 801458
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.40(a)Document locations, Dissemination, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - production units
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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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