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

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.