Medtronic MiniMed, Inc. – FDA 483, Jul 7, 2021

Medtronic MiniMed in Northridge, CA, was cited for significant deficiencies in its quality system, particularly concerning corrective and preventive actions (CAPA), complaint handling, and Medical Device Reporting (MDR). The inspection revealed failures to adequately assess and mitigate risks associated with insulin pump retainer rings and cybersecurity vulnerabilities, leading to delayed and ineffective recalls, and a failure to thoroughly investigate device malfunctions and submit timely MDRs for serious adverse events, including deaths and serious injuries.