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Thursday, October 31, 2024

FDA conducted second lowest number of inspections on Biologics companies in Wisconsin during Q2 2023

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Vid Desai FDA’s Chief Information Officer | Official Website

Vid Desai FDA’s Chief Information Officer | Official Website

In the second quarter of 2023, two Biologics 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 2.6% of all inspections in the second 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 Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring2----
Blood and Blood Products2----
Colors and Cosmetics Technology3----
Compliance: Devices33--
Drug Quality Assurance--11
Food Composition, Standards, Labeling and Econ--4--
Foodborne Biological Hazards318--
Monitoring of Marketed Animal Drugs, Feed, and Devices127--
Postmarket Assurance: Devices4----
Technical Assistance: Food and Cosmetics2----

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