FDA 483 - MRP, LLC dba Aquabiliti - February 27, 2020

MRP, LLC in Nashville, TN, a medical device manufacturer, was inspected by the FDA from February 18-27, 2020. The inspection revealed three significant observations related to inadequate design verification, deficiencies in corrective and preventive action procedures, and a lack of valid statistical rationale for stability studies. These issues indicate a need for improved quality system controls, particularly in product design and process validation.