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Friday, November 22, 2024

Missouri: Biologics companies were the third most FDA inspected companies in Missouri in Q4 2023

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In the fourth quarter of 2023, five Biologics companies received five FDA inspections in Missouri, 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 Missouri, equalling 8.5% of all inspections 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.

Top 10 FDA Inspections by Number of Actions Indicated in Missouri During Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products5----
Colors and Cosmetics Technology1----
Compliance: Devices11--
Drug Quality Assurance--5--
Food Composition, Standards, Labeling and Econ62--
Foodborne Biological Hazards361--
Human Cellular, Tissue, and Gene Therapies3----
Monitoring of Marketed Animal Drugs, Feed, and Devices41--
Postmarket Assurance: Devices2----

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