www.fdanews.com/articles/123439-medtronic-cardiac-unit-warned-for-poor-purchasing-controls
Medtronic Cardiac Unit Warned for Poor Purchasing Controls
January 6, 2010
Medtronic’s cardiac rhythm management unit has received a warning letter for purchasing control failures and other good manufacturing practice
deficiencies. FDA inspectors were not able to find any record that indicated a performance review was done on a supplier between 2002 and 2007 even though
Medtronic’s supplier quality management strategy required regular evaluations, according to the Nov. 9 letter posted recently to the agency website.
The GMP Letter
The GMP Letter