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Wednesday, May 1, 2024

FDA conducted second highest number of inspections on Biologics companies in Louisiana during Q3 2023

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Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

In the third quarter of 2023, nine Biologics companies received nine FDA inspections in Louisiana, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Louisiana, equalling 34.6% of all inspections in the third 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.

FDA Inspections in Louisiana During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products7----
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ1----
Foodborne Biological Hazards72--
Human Cellular, Tissue, and Gene Therapies3----
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Technical Assistance: Food and Cosmetics2----
Tobacco Post-Market Activities--1--

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