FDA 483 - PAVmed Inc. - April 15, 2022

An FDA inspection of PAVmed Inc., a medical device manufacturer in Foxborough, MA, identified two observations. The firm was cited for inadequate procedures for receiving, reviewing, and evaluating complaints, specifically regarding the investigation of complaint #21001. Additionally, corrective and preventive action activities and their results, including effectiveness checks for CAPA# 2020-002, were not adequately documented.