2021-12-15 오후 9:54:19
** Shares of medical device maker, Medtronic PLC MDT.N down ~4% at $107.18 premarket
** Co received a warning letter from the U.S. FDA on Dec. 9 for its Northridge, California facility, which is the headquarters for co's diabetes business (Full Story)
** The letter focuses on the inadequacy of?specific medical device quality system requirements in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and the reporting of adverse events
** The letter was issued following an inspection in July 2021 related to recalls of certain MDT products
** MDT says it will apply resources from across the company and utilize external experts to implement a range of corrective actions
** Co is not recommending any action by patients or their healthcare providers as a result of this warning letter
** Up to Tuesday's close, stock had fallen 4.65% YTD
(Reporting by Oishee Majumdar in Bengaluru)
(( oishee.majumdar@thomsonreuters.com ;))
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