# FDA 483 - Exactech, Inc. - March 10, 2017

Source: https://www.keypedia.com/records/483/exactech-inc/e2313741-d88a-4b64-984f-4c800547ba2f

> FDA 483 for Exactech, Inc. on March 10, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exactech, Inc.
- Inspection Date: 2017-03-10
- 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 cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed inadequate procedures for corrective and preventive actions, design validation, complaint handling, supplier quality management, risk analysis, and employee training. Furthermore, the firm failed to submit multiple Medical Device Reports (MDRs) to the FDA within the required 30-day timeframe, indicating serious issues with post-market surveillance and regulatory compliance.

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## Related Officers

- [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