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Tuesday, December 3, 2024

FDA conducted lowest number of inspections on Biologics companies in Tennessee during December 2023

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Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

In December 2023, two Biologics companies received two FDA inspections in Tennessee, according to the U.S. Food and Drug Administration (FDA).

This was the lowest number of inspections per type of company made by the FDA in Tennessee, equalling 15.4% of all inspections in December 2023.

Of all the Tennessee companies involved in Biologics, Fertility Center, LLC received the most citations from the FDA in December 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 December 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products2----
Compliance: Devices--2--
Food Composition, Standards, Labeling and Econ--1--
Foodborne Biological Hazards32--
Human Cellular, Tissue, and Gene Therapies11--
Postmarket Assurance: Devices11--
Technical Assistance: Food and Cosmetics--1--
Tobacco Post-Market Activities3----

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