# FDA 483 - Exactech, Inc. - January 31, 2020

Source: https://www.keypedia.com/records/483/exactech-inc/d3321ba3-277b-453a-9bcb-707182c47179

> FDA 483 for Exactech, Inc. on January 31, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exactech, Inc.
- Inspection Date: 2020-01-31
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Exactech, Inc. in Gainesville, FL, a medical device manufacturer, was inspected by the FDA from January 27-31, 2020. The inspection revealed significant deficiencies across its quality system, particularly concerning corrective and preventive actions, design controls, supplier quality, nonconforming product control, and risk analysis. These issues indicate a systemic failure to adequately establish and follow procedures crucial for ensuring product quality and patient safety.

## Related Documents

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/lisa-a-warner/3c039e9f-4349-4f3c-bac0-4d12c2cc0660)
- [Principal ](https://www.keypedia.com/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

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