# FDA 483 - Exactech, Inc. - August 22, 2003

Source: https://www.globalkeysolutions.net/records/483/exactech-inc/62f74277-82d6-4797-9cd6-55611e71e194

> FDA 483 for Exactech, Inc. on August 22, 2003. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exactech, Inc.
- Inspection Date: 2003-08-22
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Exactech, Inc., a human tissue establishment in Gainesville, FL, was cited for failing to ensure tissue suitable for transplantation was accompanied by complete donor records. The firm did not receive or maintain relevant donor medical records and had not audited its tissue suppliers since 2000. This indicates significant deficiencies in record-keeping and supplier oversight for tissue safety.

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## Related Officers

- [Holly M. Scott](https://www.globalkeysolutions.net/people/holly-m-scott/ff4a8a77-20a1-459f-b193-4a078a1d4d18)

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

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