FDA 483 - Rockwell Medical, Inc - November 20, 2025

Rockwell Medical, Inc. in Wixom, MI, was inspected and received a Form FDA 483 with three observations. The inspection revealed deficiencies in documenting non-reporting decisions for product corrections/removals, inadequate corrective and preventive action procedures, and insufficient response to out-of-tolerance test equipment. These issues indicate a lack of robust quality system controls for device manufacturing and complaint handling.