Medtronic (NYSE:MDT) announced today that the FDA lifted the warning letter related to its Diabetes business unit headquarters.
In December 2021, the FDA issued a warning letter to Medtronic’s Northridge, California, Diabetes headquarters.
The letter centered around the inadequacy of specific medical device quality system requirements at the Northridge facility. It scrutinized the areas of risk assessment, corrective and preventive action and complaint handling. The letter also related to device recalls and the reporting of adverse events.
Medtronic said today that the resolution follows ongoing remediation from the company. It took proactive actions to continue to strengthen its quality systems, according to a news release. All regulatory restrictions associated with the letter are resolved, the company said.
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