FDA: Medtronic Manufacturing Violations Could Lead to Patient Injuries
August 21st, 2012 tmccoy
The Food and Drug Administration (FDA) warned Medtronic Inc., that certain devices the company manufactured violated both manufacturing and quality regulations that may lead to injured patients.
The warning letter to Medtronic, Inc. dated July 17, 2012, stated that the company did not “establish adequate procedures for corrective and preventative action and for receiving and evaluating complaints.”
Medtronic had responded to complaints, and had tried to mitigate some risk, but the FDA felt that they had not done enough. The FDA told Medtronic that they must quickly correct the violations, and if they do not, regulatory action without further notice may occur.
The FDA also told Medtronic that it will not give approval to any device that is in the class device that is related to the violation until all of the violations have been cleaned up.
