# FDA 483 - Arthrex, Inc. - January 13, 2025

Source: https://www.keypedia.com/records/483/arthrex-inc/14aa3216-f2de-4704-9684-27c19ae5bbae

> FDA 483 for Arthrex, Inc. on January 13, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Arthrex, Inc.
- Inspection Date: 2025-01-13
- Product Type: device
- Office Name: Florida District Office
- Summary: Arthrex, Inc. in Naples, FL, a specification developer, was cited with two observations during an FDA inspection. The firm failed to adequately establish and implement procedures for receiving, reviewing, and evaluating complaints, with instances of complaints closed without proper investigation. Additionally, the firm did not adequately implement its medical device reportable event procedures, resulting in numerous late reports.

## Related Documents

- [483 - 2023-05-05](https://www.keypedia.com/records/483/arthrex-inc/a4c87741-bc0e-439d-b521-920db2e08c6f)

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9