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FDA medical device establishment inspections worldwide 2009-2020

Total number of inspections of medical device establishments by the FDA from 2009 to 2020*

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Release date

May 2021


United States

Survey time period

FY 2009 to FY 2020

Supplementary notes

* Including domestic and abroad device establishment inspections.
"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.
The statistic was assembled from several FDA reports.

** Estimate.

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Statistics on "Pharmaceutical and medical device recalls in the U.S."

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