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Minnesota State Wire

Wednesday, April 23, 2025

Minnesota: Device companies were the second most FDA inspected companies in Minnesota in Q1

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In the first quarter of 2025, eight device companies received eight 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 23.5% of all inspections in the first quarter of 2025.

Of all the Minnesota companies involved in the device sector, Junopacific, Inc. received the most citations from the FDA in the first 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.

Top 10 FDA Inspections by Number of Actions Indicated in Minnesota During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1
Blood and Blood Products1
Colors and Cosmetics Technology1
Compliance: Devices34
Drug Quality Assurance1
Foodborne Biological Hazards56
Human Cellular, Tissue, and Gene Therapies3
Monitoring of Marketed Animal Drugs, Feed, and Devices31
Postmarket Assurance: Devices22
Technical Assistance: Food and Cosmetics41

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