# FDA 483 - Turbett Surgical, Inc. - November 06, 2025

Source: https://www.keypedia.com/records/483/turbett-surgical-inc/12f52132-5418-4665-acc9-83c293d82651

> FDA 483 for Turbett Surgical, Inc. on November 06, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Turbett Surgical, Inc.
- Inspection Date: 2025-11-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Turbett Surgical, Inc. in Henrietta, NY, a specification developer and manufacturer, received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning complaint handling, corrective and preventive actions, rework procedures for nonconforming products, and the establishment of statistical techniques. These issues indicate a lack of adequate procedures and documentation for critical quality processes.

## Related Documents

- [483 - 2023-06-26](https://www.keypedia.com/records/483/turbett-surgical-inc/7c25efe3-b7f4-44b9-8a03-1da4ab34c95e)

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

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

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