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

Rockwell Medical, Inc. was subject to an FDA inspection from November 18-20, 2025, at its manufacturing facility in Wixom, MI. The inspection identified critical lapses in the company's quality system. A primary concern was the firm's failure to adequately document justifications for not reporting product correction or removal actions to the FDA, specifically concerning the distribution of expired and mislabeled Class II medical devices. The company's procedures for recalls, corrections, and removals lacked clear documentation requirements for determining FDA reporting obligations.

Additionally, the inspection revealed deficiencies in Rockwell Medical's Corrective Action / Preventive Action (CAPA) system. The existing CAPA procedures lacked specific criteria for initiating corrective and preventive actions, as demonstrated by customer complaints involving non-conforming products that were not subjected to documented CAPA investigations.

Finally, the firm failed to take appropriate action when a platform scale, a critical piece of test equipment, was found to be out of tolerance on two separate occasions. Contrary to its own calibration program, Rockwell Medical did not initiate nonconformance reports or evaluate the potential impact on device quality. The company is now required to conduct thorough internal self-audits, implement comprehensive corrective actions, and ensure full compliance with quality system regulations to rectify these issues.