Medtronic Cardiac Unit Warned for Poor Purchasing Controls

Medtronic’s cardiac rhythm management unit has received a warning letter for purchasing control failures and other GMP 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.

Further, the Mounds View, Minn., facility only tested one lot of a particular component to qualify it, which violated the company’s component/material qualification and characterization procedure.
The GMP Letter