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Wednesday, November 13, 2024

Which type of Tennessee companies were inspected the most by FDA in Q3?

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

In the third 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 highest number of inspections per type of company made by the FDA in Tennessee, equalling 31.8% of all inspections in the third quarter of 2024.

Of all the Tennessee companies involved in the Biologics sector, Fertility Center, LLC received the most citations from the FDA in the third 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 Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products2----
Compliance: Devices1----
Drug Quality Assurance21--
Foodborne Biological Hazards5----
Human Cellular, Tissue, and Gene Therapies31--
Monitoring of Marketed Animal Drugs, Feed, and Devices3----
Technical Assistance: Food and Cosmetics3----

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