# FDA 483 - Turbett Surgical, Inc. - June 26, 2023

Source: https://www.globalkeysolutions.net/records/483/turbett-surgical-inc/7c25efe3-b7f4-44b9-8a03-1da4ab34c95e

> FDA 483 for Turbett Surgical, Inc. on June 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Turbett Surgical, Inc.
- Inspection Date: 2023-06-26
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Turbett Surgical, Inc. in Henrietta, NY, a medical device specification developer, was inspected by the FDA from June 12-26, 2023. The inspection revealed significant deficiencies in their quality system, particularly concerning design controls, validation processes, corrective and preventive actions, and complaint handling. Several observations were repeats from a previous inspection, indicating persistent issues that could impact device safety and effectiveness.

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/turbett-surgical-inc/a71324e7-8c3e-43e9-ada6-56e71db45e74

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961