FDA 483 - BURTON MEDICAL - October 30, 2019

BURTON MEDICAL in Addison, IL, a medical device manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed inadequate procedures for design validation and design changes related to their AIM product family's spring arm collar. Additionally, the firm failed to adequately establish procedures for corrective and preventive actions, and did not properly evaluate complaints for Medical Device Report (MDR) reportability, leading to unsubmitted MDRs for serious device malfunctions.