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Tuesday, December 3, 2024

Wisconsin: Device companies were the second least FDA inspected companies in Wisconsin in Q4 2023

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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 fourth quarter of 2023, three device companies received three 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 5.1% of all inspections in the fourth quarter of 2023.

Of all the Wisconsin companies involved in the device sector, Daniels Manufacturing Operations, Inc. received the most citations from the FDA in the fourth quarter of 2023.

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 Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products1----
Compliance: Devices--3--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ33--
Foodborne Biological Hazards218--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices187--
Technical Assistance: Food and Cosmetics2----

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