FDA 483 - Clarus Medical, Llc - March 10, 2021

Clarus Medical, Llc, a medical device manufacturer in Minneapolis, MN, was cited by the FDA for deficiencies in its quality system. The inspection revealed that the firm's procedures for corrective and preventive action (CAPA) were not adequately established, specifically lacking documented evidence to verify the effectiveness of implemented CAPAs. This indicates a significant breakdown in ensuring that corrective actions are properly validated and do not adversely affect finished devices.