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Saturday, May 18, 2024

FDA Inspection: What type of Illinois companies were under most scrutiny during Q2 2023?

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

In the second quarter of 2023, 80 Food and Cosmetics companies received 80 FDA inspections in Illinois, according to the U.S. Food and Drug Administration (FDA).

This was the highest number of inspections per type of company made by the FDA in Illinois, equalling 72.7% of all inspections in the second quarter of 2023.

Of all the Illinois companies involved in the Food and Cosmetics sector, New Royal Distributors 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----

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