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Wednesday, November 13, 2024

Wisconsin: Device companies were the second least FDA inspected companies in Wisconsin in Q3

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Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

In the third quarter of 2024, two device companies received two FDA inspections in Wisconsin, 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 Wisconsin, equalling 8.7% of all inspections in the third quarter of 2024.

Of all the Wisconsin companies involved in the device sector, Little Rapids Corporation received the most citations from the FDA in the third 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 Wisconsin During Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products3----
Compliance: Devices11--
Drug Quality Assurance1----
Food Composition, Standards, Labeling and Econ21--
Foodborne Biological Hazards103--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices21--
Postmarket Assurance: Devices--1--

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