FDA 483 - Caerus Corp. dba Orthocor Medical - November 22, 2022

An FDA inspection of Caerus Corp. dba Orthocor Medical in Blaine, MN, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, control of nonconforming products, and the receiving, reviewing, and evaluating of complaints. These issues led to unaddressed product failures and a lack of proper investigation into customer complaints.