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Wednesday, September 10, 2025

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

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

In the first quarter of 2025, seven device companies received seven FDA inspections in Wisconsin, 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 Wisconsin, equalling 33.3% of all inspections in the first quarter of 2025.

Of all the Wisconsin companies involved in the device sector, Plexus Corporation 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.

FDA Inspections in Wisconsin During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1
Compliance: Devices61
Food Composition, Standards, Labeling and Econ2
Foodborne Biological Hazards91
Monitoring of Marketed Animal Drugs, Feed, and Devices2
Postmarket Assurance: Devices5
Technical Assistance: Food and Cosmetics2

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