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Thursday, October 31, 2024

Wisconsin: Biologics companies were the second most 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, three Biologics companies received three 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 13% of all inspections 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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