Medtronic Diabetes receives FDA warning letter
Medtronic plc (NYSE:MDT) received a warning letter from the FDA on December 9, 2021, concerning its Northridge, California facility, primarily addressing quality system inadequacies linked to the MiniMed™ insulin infusion pumps. The letter followed an inspection completed in July 2021 and highlighted issues in risk assessment, complaint handling, and device recalls. Medtronic is focused on resolving these issues with internal and external resources, emphasizing its commitment to product safety and the well-being of diabetes patients. No actions are recommended for patients or healthcare providers.
- Commitment to resolving FDA observations and improving quality systems.
- No action required from patients or healthcare providers, ensuring continuity of care.
- FDA warning letter reflects significant quality system deficiencies.
- Issues could lead to potential reputational damage and regulatory scrutiny.
DUBLIN, Dec. 15, 2021 /PRNewswire/ -- Medtronic plc (NYSE:MDT) today announced it received a warning letter from the U.S. Food and Drug Administration (FDA) on December 9 for the company's Northridge, California, facility, the headquarters for its Diabetes Business. The warning letter was issued following an inspection that concluded in July 2021 related to recalls of the MiniMed™ 600 series insulin infusion pump, and a remote controller device for MiniMed™ 508 and Paradigm™ pumps.
The warning letter focuses on the inadequacy of specific medical device quality system requirements at the Northridge facility in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.
"We are committed to fully resolving all observations as effectively and quickly as possible. Nothing is more important to us than providing the highest quality products to people living with diabetes," said Sean Salmon, executive vice president and president of the Diabetes business at Medtronic.
To ensure the most effective response to the warning letter, Medtronic will apply resources from across the company and utilize external experts. The company is implementing a range of corrective actions and process improvements related to the observations, and will continue reviewing these actions with the FDA.
Medtronic is not recommending any action by patients or their healthcare providers as a result of this warning letter.
"Every day millions of people living with diabetes around the world rely on the innovations we deliver, and Medtronic remains deeply committed to ensuring their safety and well-being," said Salmon.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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Public Relations | Investor Relations |
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SOURCE Medtronic plc
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