FDA 483 - Wexler Surgical, Inc. - July 30, 2025

Wexler Surgical, Inc. in Houston, TX, was inspected by the FDA, resulting in three observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, and design control and validation processes. These issues indicate a lack of adherence to established procedures and a failure to adequately ensure product quality and safety.