FDA 483 - Acist Medical Systems - March 04, 2019

Acist Medical Systems in Eden Prairie, MN, was inspected by the FDA from February 27 to March 4, 2019. The inspection resulted in one observation related to inadequate documentation of corrective and preventive action activities. Specifically, the firm failed to document actions taken to correct and prevent recurrence of nonconforming product and the verification of effectiveness for those actions.