Medical Device Firms Experiencing "Death by CAPA?"
Majority of Warning Letters Caused by CAPA Deficiencies
Eighty-eight percent of all Warning Letters issued by the FDA to medical device firms recently were related to CAPA deficiencies. Managing the CAPA process is a major challenge for most medical device companies. This problem can be so overwhelming that an FDA official called it "death by CAPA."Is your CAPA system helping or "killing" your organization? In the next issue, an article by Ken Peterson, senior partner of PathWise Inc., a leading CAPA training and consulting provider, will examine risk-based filters that you can use to regulate the input flow of deviations into the CAPA system.