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Minnesota State Wire

Tuesday, September 9, 2025

Minnesota: Biologics companies were the second least FDA inspected companies in Minnesota in Q2

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

In the second quarter of 2025, two Biologics companies received two 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 4.3% of all inspections in the second quarter of 2025.

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.

FDA Inspections in Minnesota During Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring4
Compliance: Devices76
Foodborne Biological Hazards84
Human Cellular, Tissue, and Gene Therapies1
Monitoring of Marketed Animal Drugs, Feed, and Devices8
Postmarket Assurance: Devices7
Technical Assistance: Food and Cosmetics9

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