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

Source: https://www.keypedia.com/records/483/exactech-sarasota-inc/eba1ad74-ee57-4e32-a0ef-df91111eea58

> 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: Florida District Office
- Summary: Exactech Sarasota, Inc. received a Form FDA-483 with seven observations detailing significant quality system deficiencies. The inspection revealed inadequate procedures across multiple areas, including process controls, corrective and preventive actions, nonconforming product handling, environmental monitoring, supplier management, training, and acceptance activities. These issues collectively indicate a broad failure to ensure device conformance to specifications and maintain a robust quality system.

## Related Documents

- [483 - 2025-07-25](https://www.keypedia.com/records/483/exactech-sarasota-inc/2f25f0ce-905f-4e7c-8ab0-fc4a56f61c7c)

## Related Officers

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

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

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