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Sunday, December 22, 2024

FDA conducted second highest number of inspections on Biologics companies in Tennessee during Q2 2023

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

In the second quarter of 2023, 12 Biologics companies received 12 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 27.9% of all inspections in the second 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.

FDA Inspections in Tennessee During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring6----
Blood and Blood Products10----
Compliance: Devices321
Drug Quality Assurance3----
Food Composition, Standards, Labeling and Econ41--
Foodborne Biological Hazards105--
Human Cellular, Tissue, and Gene Therapies4----
Postmarket Assurance: Devices5----
Vaccines and Allergenic Products3----

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