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Show-Me State Times

Wednesday, September 18, 2024

Missouri: Biologics companies were the least FDA inspected companies in Missouri in Q1

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In the first quarter of 2024, two Biologics companies received two FDA inspections in Missouri, according to the U.S. Food and Drug Administration (FDA).

This was the lowest number of inspections per type of company made by the FDA in Missouri, equalling 4% of all inspections in the first quarter of 2024.

Of all the Missouri companies involved in the Biologics sector, Center for Reproductive Medicine & Robotic Surgery, LLC received the most citations from the FDA in the first quarter of 2024.

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 Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products11--
Compliance: Devices22--
Drug Quality Assurance12--
Food Composition, Standards, Labeling and Econ3----
Food and Color Additives Petition Review2----
Foodborne Biological Hazards273--
Human Cellular, Tissue, and Gene Therapies11--
Monitoring of Marketed Animal Drugs, Feed, and Devices7----
Postmarket Assurance: Devices4----
Technical Assistance: Food and Cosmetics4----

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