FDA 483 - Covidien LP - November 18, 2022

An FDA inspection of Covidien LP in Mansfield, MA, a medical device manufacturer, revealed significant deficiencies in their complaint handling procedures. The firm failed to establish adequate timeframes for processing product complaints, resulting in substantial delays in opening and completing investigations. This led to a failure to timely report a reportable event to the FDA, indicating a serious lapse in their quality system.