FDA 483 - Johnson Medtech LLC - November 27, 2023

Johnson Medtech LLC, a medical device manufacturer in Vandalia, OH, received a Form FDA 483 with four repeat observations. The inspection revealed significant deficiencies in process validation, production process control, corrective and preventive action procedures, and product acceptance status. These issues indicate a systemic lack of adherence to quality system requirements, posing potential risks to device quality and patient safety.