Medtronic Puerto Rico Operations Co. – FDA EIR, May 15, 2018

The FDA conducted an unannounced, for-cause inspection of Medtronic Puerto Rico Operations Co. from April 23 to May 15, 2018, focusing on Class II and III medical devices, including implantable cardiac defibrillators and insulin pumps. This inspection followed a previous for-cause inspection in August 2017 that also resulted in an FDA-483. The current inspection identified six objectionable observations, resulting in the issuance of another FDA-483 form. Key issues included the inadequacy of the corrective and preventive action (CAPA) system, particularly concerning confirmed electrical arcing failures in implantable cardiac defibrillators. The firm's CAPA procedures were found to be insufficiently implemented, not commensurate with identified risks, and failed to adequately address the significance of failures or prevent recurrence, with corrective actions not always reflected in production procedures. Furthermore, critical process validation activities were found to be inadequate for device specifications that cannot be fully verified by subsequent inspection, such as the newly defined specification for arcing failures in implantable defibrillators. These violations indicate non-compliance with the U.S. Food, Drug, and Cosmetic Act and relevant portions of 21 Code of Federal Regulations, specifically pertaining to Quality System Regulation requirements for corrective and preventive actions (21 CFR 820.100(a)) and process validation (21 CFR 820.75(a)). Management "promised to correct" these observations, and a written response was encouraged to address the deficiencies.