Cogmedix, Inc. – FDA 483, Apr 11, 2024

Cogmedix, Inc. in West Boylston, MA, a medical device establishment, was cited for several quality system deficiencies during an FDA inspection. Observations included failure to report accidental radiation occurrences, inadequate procedures for rework of nonconforming products, and insufficient corrective and preventive action processes. Additionally, the firm's supplier requirements and evaluation methods were found to be inadequately established.