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Minnesota State Wire

Wednesday, April 23, 2025

FDA conducted second lowest number of inspections on Biologics companies in Minnesota during Q4 2024

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In the fourth 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 lowest number of inspections per type of company made by the FDA in Minnesota, equalling 7.9% of all inspections in the fourth quarter of 2024.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

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

Top 10 FDA Inspections by Number of Actions Indicated in Minnesota During Q4 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1
Blood and Blood Products2
Colors and Cosmetics Technology1
Compliance: Devices53
Drug Quality Assurance11
Food Composition, Standards, Labeling and Econ2
Foodborne Biological Hazards77
Monitoring of Marketed Animal Drugs, Feed, and Devices11
Postmarket Assurance: Devices6
Technical Assistance: Food and Cosmetics8

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