Quantcast

Prairie State Wire

Friday, November 15, 2024

FDA conducted third highest number of inspections on Biologics companies in Illinois during Q2 2023

Webp 51tcce8qtq0gv3h0ttdr040fsao9

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 second quarter of 2023, nine Biologics companies received nine FDA inspections in Illinois, 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 Illinois, equalling 8.2% of all inspections in the second quarter of 2023.

Of all the Illinois companies involved in the Biologics sector, Randy Morris School, M.D. received the most citations from the FDA 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 Illinois During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring7----
Blood and Blood Products6----
Compliance: Devices82--
Drug Quality Assurance--4--
Food Composition, Standards, Labeling and Econ111--
Foodborne Biological Hazards56231
Human Cellular, Tissue, and Gene Therapies61--
Monitoring of Marketed Animal Drugs, Feed, and Devices2----
Postmarket Assurance: Devices9----
Vaccines and Allergenic Products4----

MORE NEWS