FDA 483 - Radialogica LLC - March 06, 2024

Radialogica LLC, a medical device manufacturer in Saint Louis, MO, was cited with three observations during an FDA inspection. The inspection revealed deficiencies in the establishment and maintenance of procedures for corrective and preventive actions, inadequate maintenance of complaint files (a repeat observation from 2018), and inadequately established procedures for design review, specifically regarding independent review participation. These issues indicate significant gaps in the firm's quality system.