FDA Sends Warning Letter to Medtronic Inc

Boston (DbTechNo) – It is being reported that the FDA (Food and Drug Administration) have issued a warning letter to Medtronic Inc, due to a bad inspection at their facility in Mounds View, Minnesota.

The company makes medical devices, including defibrillators that millions of Americans rely on each and every day of their lives.

Back in August the FDA inspected the Minnesota plant, and found a number of areas of concern which prompted the warning letter.

Areas of concern laid out in the letter include preventive action measures, proper documentation of field action recommendations and better information on suppliers.

As required companies who are sent warning letters, have 15 days to submit a response and Medtronic have confirmed their intent to do just that.

The company also stated that they have already begun to make corrections to their plant, based on the recommendations laid out in the FDA letter.

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