# FDA 483 - Exactech, Inc. - August 27, 2025

Source: https://www.keypedia.com/records/483/exactech-inc/d0550fd9-f549-4bd9-abc6-6ebc0af9e221

> FDA 483 for Exactech, Inc. on August 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exactech, Inc.
- Inspection Date: 2025-08-27
- Product Type: device
- Office Name: Florida District Office
- Summary: Exactech, Inc. in Gainesville, FL, received a Form FDA 483 with nine observations highlighting significant deficiencies in their quality system for orthopedic implants. The inspection revealed inadequate design verification and input documentation, unvalidated sterilization and vacuum sealing processes, and failures in corrective actions, supplier quality management, change control, and risk analysis. These findings indicate a need for comprehensive improvements to ensure product quality and patient safety.

## Related Documents

- [WARNING_LETTER - 2025-07-25](https://www.keypedia.com/records/warning_letter/exactech-inc/43ec8064-a2fb-467e-89be-2f6aa976a8a3)
- [EIR - 2021-11-17](https://www.keypedia.com/records/eir/exactech-inc/b983da53-5bfc-4170-9501-1900b542ebfc)
- [483 - 2023-09-26](https://www.keypedia.com/records/483/exactech-inc/6ce36dfd-0f2a-4236-b8e2-7a68eba11289)
- [EIR - 2020-01-31](https://www.keypedia.com/records/eir/exactech-inc/e7fa2a45-ffaa-41b5-8668-608aad7b9ca7)
- [483 - 2020-01-31](https://www.keypedia.com/records/483/exactech-inc/d3321ba3-277b-453a-9bcb-707182c47179)

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)
- [Mary A. Millner](https://www.keypedia.com/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

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

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