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Saturday, December 21, 2024

Tennessee: Biologics companies were the second most FDA inspected companies in Tennessee in Q2

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In the second quarter of 2024, three Biologics companies received three FDA inspections in Tennessee, 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 Tennessee, equalling 21.4% of all inspections in the second 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.

FDA Inspections in Tennessee During Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products2----
Compliance: Devices1----
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ1----
Foodborne Biological Hazards53--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices--1--
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics2----

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