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Sunday, May 5, 2024

FDA conducted second lowest number of inspections on Biologics companies in Missouri during 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 2023, 18 Biologics companies received 18 FDA inspections in Missouri, 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 Missouri, equalling 7.6% of all inspections in 2023.

Of all the Missouri companies involved in the Biologics sector, SSM-SLUH, Inc. received the most citations from the FDA in 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 Missouri During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring181--
Blood and Blood Products121--
Compliance: Devices510--
Drug Quality Assurance3111
Food Composition, Standards, Labeling and Econ1951
Foodborne Biological Hazards11073
Human Cellular, Tissue, and Gene Therapies6----
Monitoring of Marketed Animal Drugs, Feed, and Devices2741
Postmarket Assurance: Devices112--
Technical Assistance: Food and Cosmetics191--

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