# FDA 483 - Avanos Medical, Inc. - December 15, 2023

Source: https://www.keypedia.com/records/483/avanos-medical-inc/b6bb4d74-a5ae-4462-aa27-811be5517ecc

> FDA 483 for Avanos Medical, Inc. on December 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avanos Medical, Inc.
- Inspection Date: 2023-12-15
- Product Type: device
- Office Name: Center for Devices and Radiological Health
- Summary: An FDA inspection of Avanos Medical, Inc. in Alpharetta, GA, a specification developer, revealed significant deficiencies in its quality system, particularly concerning corrective and preventive actions, risk analysis, and complaint handling. The firm failed to adequately investigate root causes for adverse events, including those leading to Class I recalls for its CORTRAK 2 Enteral Access System and BALLARD ACCESS Closed Suction System, and did not maintain adequate risk analyses or complaint investigation documentation. These issues indicate a systemic breakdown in ensuring product safety and quality.

## Related Documents

- [EIR - 2018-10-02](https://www.keypedia.com/records/eir/avanos-medical-inc/1d963cda-94c0-4987-92a6-2c442e015e12)

## Related Officers

- [Jamie P. Webb](https://www.keypedia.com/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)
- [Mary A. Millner](https://www.keypedia.com/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

Company: https://www.keypedia.com/companies/avanos-medical-inc/6c032a92-1728-4a28-a470-a915c8c39b98

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7