# FDA 483 - Arthrex, Inc. - May 05, 2023

Source: https://www.globalkeysolutions.net/records/483/arthrex-inc/a4c87741-bc0e-439d-b521-920db2e08c6f

> FDA 483 for Arthrex, Inc. on May 05, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arthrex, Inc.
- Inspection Date: 2023-05-05
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Arthrex, Inc. in Naples, FL, revealed significant deficiencies in their quality system. The firm was cited for failing to adequately establish and implement procedures for receiving, reviewing, and evaluating complaints, leading to inconsistent application of complaint definitions and inadequate investigations. Additionally, the inspection found that written Medical Device Report (MDR) procedures were not adequately implemented, resulting in untimely reporting of reportable events and failure to report certain malfunctions.

## Related Documents

- [483 - 2025-01-13](https://www.globalkeysolutions.net/records/483/arthrex-inc/14aa3216-f2de-4704-9684-27c19ae5bbae)

## Related Officers

- [Dianiris C. Ayala](https://www.globalkeysolutions.net/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)
- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.globalkeysolutions.net/companies/arthrex-inc/e18abb8a-3bf8-462d-b279-f969cd710c14

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6