For Medical Devices
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."