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Tuesday, May 21, 2024

Louisiana: Biologics companies were the second most FDA inspected companies in Louisiana in Q2 2023

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

In the second 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 28.1% of all inspections in the second quarter of 2023.

Of all the Louisiana companies involved in the Biologics sector, Biomat USA, Inc. 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.

FDA Inspections in Louisiana During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products61--
Food Composition, Standards, Labeling and Econ1----
Foodborne Biological Hazards15----
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices21--
Technical Assistance: Food and Cosmetics10----
Vaccines and Allergenic Products11--

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