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Friday, November 1, 2024

Tennessee: Biologics companies were the third most FDA inspected companies in Tennessee in Q3 2023

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Vid Desai FDA’s Chief Information Officer | Official Website

Vid Desai FDA’s Chief Information Officer | Official Website

In the third quarter of 2023, eight Biologics companies received eight 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 16.7% of all inspections in the third 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 Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring5----
Blood and Blood Products4----
Compliance: Devices83--
Drug Quality Assurance--11
Food Composition, Standards, Labeling and Econ21--
Foodborne Biological Hazards133--
Human Cellular, Tissue, and Gene Therapies3----
Monitoring of Marketed Animal Drugs, Feed, and Devices6----
Postmarket Assurance: Devices101--
Technical Assistance: Food and Cosmetics1----

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