FDA EIR - Abbott Medical - June 28, 2023

An FDA inspection conducted at Abbott Medical's Sylmar, CA facility from June 20-28, 2023, revealed significant violations concerning the quality system for medical devices. The inspection focused on Abbott Cardiac Rhythm Management operations, a manufacturer of implantable cardioverter defibrillators. A primary observation was the company's failure to report corrections or removals to the FDA, as required by regulatory frameworks. Specifically, Abbott initiated a corrective action (CAPA #127175) in response to customer complaints about Next Generation Quad (NGQ) ICDs and CRTDs losing Bluetooth Low Energy (BLE) communication. This defect, caused by a component issue leading to excessive battery drain, posed serious health risks, including potential loss of life-saving therapy and the need for additional surgeries. Despite implementing software and firmware upgrades as field corrections for potentially thousands of affected devices, the company did not inform the FDA of these critical actions. Furthermore, the FDA noted inadequate corrective and preventive action procedures. The field corrective action initiated by Abbott was insufficient, as customer notifications for the BLE issue only reached a fraction of potentially affected device users. Finally, Abbott's complaint handling procedures were found to be deficient. The company failed to properly document approximately 300 reports of device-related infections, automatically classifying them as non-reportable without adequate evaluation. Additionally, several Product Experience Reports concerning the BLE issue were incorrectly dismissed as 'non-complaints,' stemming from an internal definition of a complaint inconsistent with 21 CFR 820.3(b). Abbott Medical has promised to correct the issues related to reporting corrections and complaint handling, while the inadequacy of their corrective and preventive actions remains under consideration.