FDA 483 - C4 Imaging LLC - May 17, 2019

C4 Imaging LLC, a medical device manufacturer in Doylestown, PA, was inspected by the FDA on May 17, 2019. The inspection revealed significant deficiencies in the firm's quality system, specifically the absence of written procedures for Medical Device Reporting (MDR) and for corrective and preventive actions. These issues indicate a fundamental lack of established processes for critical quality system elements.