FDA 483 - Powers Medical Devices, LLC - April 29, 2022

Powers Medical Devices, LLC, a medical device manufacturer in Stuart, FL, was cited with three repeat observations during an FDA inspection. The firm failed to perform internal quality audits, adequately establish and implement corrective and preventive action procedures, and ensure purchased products and services conform to requirements through supplier audits. These repeat findings indicate persistent deficiencies in the firm's quality system.