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Minnesota State Wire

Friday, September 20, 2024

FDA conducted second highest number of inspections on Biologics companies in Minnesota during Q2

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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 2024, three Biologics companies received three 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 10.3% of all inspections in the second 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 Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products3----
Compliance: Devices12--
Drug Quality Assurance--1--
Foodborne Biological Hazards17--
Monitoring of Marketed Animal Drugs, Feed, and Devices21--
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics11----

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