FDA 483 - Mpi Medical Products, Inc. - December 04, 2018

This FDA Form 483 report details significant deficiencies at MPI Medical Products, Inc. in Palm Bay, FL, a medical device manufacturer. The inspection revealed multiple issues with the firm's quality system procedures, including inadequately established procedures for design changes, corrective and preventive actions, quality audits, supplier control, medical device reporting, and device history records. Several of these deficiencies were noted as repeated from previous inspections, indicating a persistent lack of compliance.