FDA 483 - Novatek, LLC - February 18, 2022

Novatek, LLC in Camarillo, CA, a medical device manufacturer, was inspected by the FDA on February 15 and 18, 2022. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the lack of established procedures for corrective and preventive actions and device history records. These findings indicate a fundamental breakdown in critical quality management processes.