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Minnesota State Wire

Friday, November 22, 2024

Minnesota: Device companies were the second most FDA inspected companies in Minnesota in Q2 2023

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

In the second quarter of 2023, 10 device companies received 10 FDA inspections in Minnesota, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Minnesota, equalling 13.7% of all inspections in the second quarter of 2023.

Of all the Minnesota companies involved in the device sector, Medtronic Neuromodulation received the most citations from the FDA in the second quarter of 2023.

The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.

The FDA is a government agency primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

FDA Inspections in Minnesota During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Compliance: Devices46--
Food Composition, Standards, Labeling and Econ4----
Foodborne Biological Hazards329--
Monitoring of Marketed Animal Drugs, Feed, and Devices241
Postmarket Assurance: Devices61--
Technical Assistance: Food and Cosmetics121--
Tobacco Post-Market Activities2----

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