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Sunday, December 22, 2024

FDA conducted third highest number of inspections on Biologics companies in Tennessee during Q1 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 first quarter of 2023, five Biologics companies received five FDA inspections in Tennessee, 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 Tennessee, equalling 12.2% of all inspections in the first quarter of 2023.

Of all the Tennessee companies involved in the Biologics sector, National Embryo Donation Center received the most citations from the FDA in the first 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 Tennessee During Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring2----
Blood and Blood Products4----
Compliance: Devices44--
Drug Quality Assurance--11
Food Composition, Standards, Labeling and Econ21--
Foodborne Biological Hazards144--
Postmarket Assurance: Devices41--
Technical Assistance: Food and Cosmetics4----
Tobacco Post-Market Activities3----
Vaccines and Allergenic Products5----

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