FDA Says Medtronic Needs Follow-Up Inspections to Confirm Corrections
The FDA hit two Medtronic device facilities with warning letters last week, citing faulty device history records and CAPA procedures.
In one warning letter following up on an April-May inspection of a Medtronic facility in Juncos, Puerto Rico, the agency noted the company failed to validate production processes for its Blackwell implantable cardiac defibrillators, leading to a recall.
In the second warning letter to Medtronic concerning its cardiac rhythm and heart failure (CHRF) facility in Mounds View, Minnesota, the agency noted that an April/May inspection of the facility found design transfer was approved for the defibrillators prior to qualification of certain processes and the processes were implemented at the Juncos manufacturing facility even though a classification was never conducted.
In response to the findings, Medtronic committed to reviewing all manufacturing processes, and assessing any of the processes at issue for current implantable therapy and diagnostic devices to evaluate the validation status of all processes that were not fully verified.
The FDA wrote in both warning letters that Medtronic’s responses to the issues appeared to be adequate, but that follow-up inspections will be necessary to confirm compliance.