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Friday, November 22, 2024

FDA conducted second lowest number of inspections on Biologics companies in Illinois during Q4 2023

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

In the fourth quarter of 2023, four Biologics companies received four FDA inspections in Illinois, 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 Illinois, equalling 7.7% of all inspections in the fourth quarter of 2023.

Of all the Illinois companies involved in the Biologics sector, Institute for Human Reproduction, School 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 Illinois During Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products21--
Compliance: Devices33--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ3----
Foodborne Biological Hazards2911--
Human Cellular, Tissue, and Gene Therapies12--
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Postmarket Assurance: Devices5----
Technical Assistance: Food and Cosmetics2----

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