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Minnesota State Wire

Sunday, December 22, 2024

Minnesota: Device companies were the second most FDA inspected companies in Minnesota in Q3

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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 third quarter of 2024, four device companies received four 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 16% of all inspections in the third quarter of 2024.

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 Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products1----
Compliance: Devices31--
Drug Quality Assurance1----
Food Composition, Standards, Labeling and Econ--1--
Foodborne Biological Hazards75--
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Postmarket Assurance: Devices3----
Technical Assistance: Food and Cosmetics5----

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