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Tuesday, April 22, 2025

Tennessee: Biologics companies were the second most FDA inspected companies in Tennessee in Q4 2024

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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 fourth quarter of 2024, seven Biologics companies received seven 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 29.2% of all inspections in the fourth quarter of 2024.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality.

FDA Inspections in Tennessee During Q4 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring4
Blood and Blood Products6
Compliance: Devices31
Drug Quality Assurance11
Food Composition, Standards, Labeling and Econ1
Foodborne Biological Hazards62
Postmarket Assurance: Devices31
Technical Assistance: Food and Cosmetics21

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