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Sunday, December 22, 2024

Illinois: Biologics companies were the second most FDA inspected companies in Illinois in Q1 2023

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In the first quarter of 2023, 13 Biologics companies received 13 FDA inspections in Illinois, 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 Illinois, equalling 11.9% of all inspections in the first quarter of 2023.

Of all the Illinois companies involved in the Biologics sector, CSL Plasma, Inc. received the most citations from the FDA 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 Illinois During Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring21--
Blood and Blood Products112--
Compliance: Devices25--
Drug Quality Assurance231
Food Composition, Standards, Labeling and Econ6----
Foodborne Biological Hazards51192
Monitoring of Marketed Animal Drugs, Feed, and Devices241
Postmarket Assurance: Devices33--
Technical Assistance: Food and Cosmetics2----
Vaccines and Allergenic Products10----

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