FDA: Medtronic Unit Not Following GMP on Implantable Pacemakers, Leads

Medtronic Inc.’s Cardiac Rhythm Disease Management unit has received a warning letter from the U.S. Food and Drug Administration saying that the firm isn’t using Good Manufacturing Practice requirements when making its implantable pacemakers and pacemaker leads.

The inspection also revealed that Minneapolis, Minn.-based Medtronic failed to submit five medical device reports on deadlines required by MedWatch Report Submission procedure, according to the letter.

Visit www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm191541.htm to view the entire warning letter.