FDA 483 - Johnson Medtech LLC - December 08, 2022

Johnson Medtech LLC, a medical device manufacturer in Vandalia, OH, was cited with six observations during an FDA inspection from November 17 to December 8, 2022. The inspection revealed significant deficiencies in process validation, corrective and preventive actions, product acceptance status, production process control, nonconforming material control, and device history records. Several observations were repeats from a previous inspection, indicating persistent issues with the firm's quality system.