# FDA 483 - Exactech, Inc. - September 26, 2023

Source: https://www.keypedia.com/records/483/exactech-inc/6ce36dfd-0f2a-4236-b8e2-7a68eba11289

> FDA 483 for Exactech, Inc. on September 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exactech, Inc.
- Inspection Date: 2023-09-26
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Exactech, Inc. in Gainesville, FL, a manufacturer of medical devices, revealed significant deficiencies in its quality system. The firm failed to adequately establish and implement procedures for corrective and preventive actions, particularly regarding complaint data analysis and risk evaluation for polyethylene shoulder implants. Additionally, Exactech did not submit 288 Medical Device Reports within the required 30-day timeframe.

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## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.keypedia.com/companies/exactech-inc/9a0525f1-06ac-4e0c-af0a-92ab3f74e9af

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