FDA 483 - rms Surgical - April 01, 2022

rms Surgical in Anoka, MN, was inspected from March 29 to April 1, 2022, and received a Form FDA 483 with two observations. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) system, including actions taken outside the formal system and a lack of verification of effectiveness. Additionally, the firm's document control procedures were found to be inadequately established and maintained.