TELECTRONICS MDR PRACTICES, COMPLAINT HANDLING CITED BY FDA
This article was originally published in The Gray Sheet
Executive Summary
TELECTRONICS MDR PRACTICES, COMPLAINT HANDLING CITED BY FDA in an Oct, 13 warning letter to the Colorado-based manufacturer of pacemakers and defibrillators. The warning letter follows a May 9 through Aug. 9 inspection of the firm's Englewood plant and the issuance of an FD-483 inspectional observation report on Aug. 10.