FDA 483 - MicroVention Costa Rica S.R.L. - May 23, 2022

MicroVention Inc. in Alajuela, Costa Rica, was inspected and cited for significant deficiencies in its quality system. Observations included inadequate process validation for catheter washing, insufficient software validation for lot tracking, and a failure to properly document quality testing results. Additionally, the firm did not adequately manage nonconformances or supplier corrective actions, indicating systemic issues in its quality control and CAPA processes.