# FDA 483 - Exactech Sarasota, Inc. - July 25, 2025

Source: https://www.globalkeysolutions.net/records/483/exactech-sarasota-inc/2f25f0ce-905f-4e7c-8ab0-fc4a56f61c7c

> FDA 483 for Exactech Sarasota, Inc. on July 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exactech Sarasota, Inc.
- Inspection Date: 2025-07-25
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Exactech Sarasota, Inc. received a Form FDA 483 following an inspection, citing significant deficiencies across its quality system. The firm failed to adequately establish and follow procedures for process controls, corrective and preventive actions, nonconforming product handling, environmental controls, supplier quality management, training, and acceptance activities. These issues indicate a systemic breakdown in ensuring device conformance to specifications and maintaining a state of control.

## Related Documents

- [483 - 2025-07-25](https://www.globalkeysolutions.net/records/483/exactech-sarasota-inc/eba1ad74-ee57-4e32-a0ef-df91111eea58)

## Related Officers

- [Christopher B. May](https://www.globalkeysolutions.net/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)
- [Katelyn A. Staub-Zamperini](https://www.globalkeysolutions.net/people/katelyn-a-staub-zamperini/bb7f95a4-53c1-473c-856e-517312bdba30)

Company: https://www.globalkeysolutions.net/companies/exactech-sarasota-inc/9fad5576-a56f-4d67-9ffe-4ca10cdf5161

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