FDA Flags Katalyst Surgical Over CAPA Procedures

The FDA issued a Form 483 to Katalyst Surgical when an agency inspection determined the firm’s Chesterfield, Missouri facility did not adequately document CAPA procedures.

The inspection revealed that the firm reviewed and signed CAPA reports before completing the necessary corrective actions and effectiveness verifications.

The firm also failed to follow its procedures for non-conforming product by not conducting formal reviews of non-conformance data.