FDA foreign and domestic medical device establishment inspections 2009-2020

Number of inspections of domestic and foreign medical device establishments by the FDA from 2009 to 2020*

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Release date

April 2022

Region

United States

Survey time period

FY 2009 to FY 2020

Supplementary notes

* "Any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept, can be subject to inspection."
Domestic and Foreign data consist of Bioresearch Monitoring Program Inspections, Pre-Market Inspections, Post-Market Audit Inspections, and GMP Inspections.

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