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Medtronic Slapped With 2 FDA Warning Letters For Problems At Minnesota, Puerto Rico Sites

 
• By Shawn M. Schmitt

Two Medtronic facilities that make cardiac rhythm management devices were sent warning letters by US FDA because of quality systems issues. The sites were inspected by the agency after the firm initiated high-risk class I recalls for an array of CRM products earlier this year.

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US FDA has sent warning letters to two Medtronic PLC facilities producing cardiac rhythm management devices that were the subject of high-risk recalls earlier this year. The agency alleges that the company's sites violated narrow portions of its Quality System Regulation.

The first missive, dated July 30 but released online Sept. 11, resulted from an FDA inspection of Medtronic's Cardiac Rhythm and Heart Failure business in Mounds View, Minn. A second letter, dated Aug

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