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Friday, November 22, 2024

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

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In 2023, 27 Biologics companies received 27 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 24.5% of all inspections in 2023.

Of all the Louisiana companies involved in the Biologics sector, Biomat USA, 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 Louisiana During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring71--
Blood and Blood Products201--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ2----
Food and Color Additives Petition Review1----
Foodborne Biological Hazards419--
Human Cellular, Tissue, and Gene Therapies7----
Monitoring of Marketed Animal Drugs, Feed, and Devices101--
Technical Assistance: Food and Cosmetics201--
Vaccines and Allergenic Products51--

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