FDA 483 - Zavation - June 20, 2019

An FDA inspection of Zavation Medical Products, LLC in Flowood, MS, identified a significant issue regarding the timely submission of Medical Device Reports (MDRs). The firm failed to submit MDRs within the required 30-day timeframe for device malfunctions that could potentially lead to death or serious injury if they recurred. This indicates a critical lapse in the company's post-market surveillance and reporting procedures.