Turbett Surgical, Inc.June 26, 2023

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

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Record Details

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.

Company: Turbett Surgical, Inc.
Inspection Date: June 26, 2023
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Matthew D. Schnittker

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ID · 7c25efe3-b7f4-44b9-8a03-1da4ab34c95e