FDA 483 - Abbott Medical - June 28, 2023

An FDA inspection of Abbott Medical in Sylmar, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to report corrections and removals for implantable cardiac devices with Bluetooth communication issues that could lead to serious injury or death. Additionally, procedures for corrective and preventive actions and complaint handling were found to be inadequate, with numerous complaints misclassified and not properly evaluated for Medical Device Report (MDR) reportability.