483
PAVmed Inc.FDA 483 - PAVmed Inc. - April 15, 2022
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Record Details
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.
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ID · f4d954eb-8ac4-44a2-ad82-d7f8a513227b