Caerus Corp. dba Orthocor Medical – FDA 483, Feb 27, 2026

Caerus Corp dba OrthoCor Medical, a medical device manufacturer in Blaine, MN, received a Form 483 for significant deficiencies in their quality system. The inspection revealed inadequate corrective and preventive actions (CAPA) that failed to address recurring product issues like charging port failures and incorrect activation for approximately four years. Additionally, the firm's risk management processes, specifically Failure Mode and Effects Analysis (FMEA) documents, did not adequately capture and assess hazard/failure modes reported through customer complaints.