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Thursday, November 21, 2024

Tennessee: Device companies were the second most FDA inspected companies in Tennessee in Q4 2023

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

In the fourth quarter of 2023, eight device companies received eight 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 20.5% of all inspections in the fourth quarter of 2023.

Of all the Tennessee companies involved in the device sector, TMJ Services, LLC received the most citations from the FDA in the fourth 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 Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products3----
Compliance: Devices43--
Drug Quality Assurance--1--
Foodborne Biological Hazards112--
Human Cellular, Tissue, and Gene Therapies21--
Monitoring of Marketed Animal Drugs, Feed, and Devices31--
Postmarket Assurance: Devices51--
Technical Assistance: Food and Cosmetics31--
Tobacco Post-Market Activities4----

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