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Wednesday, November 13, 2024

FDA conducted third highest number of inspections on Biologics companies in Wisconsin during Q1 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 first quarter of 2023, eight Biologics companies received eight FDA inspections in Wisconsin, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in Wisconsin, equalling 7.8% of all inspections in the first 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.

Top 10 FDA Inspections by Number of Actions Indicated in Wisconsin During Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring4----
Blood and Blood Products7----
Colors and Cosmetics Technology1----
Compliance: Devices2----
Food Composition, Standards, Labeling and Econ42--
Foodborne Biological Hazards5510--
Human Cellular, Tissue, and Gene Therapies3----
Monitoring of Marketed Animal Drugs, Feed, and Devices1921
Technical Assistance: Food and Cosmetics2----
Vaccines and Allergenic Products6----

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