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Wednesday, October 16, 2024

FDA conducted second highest number of inspections on Biologics companies in Tennessee during Q1

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

In the first quarter of 2024, 11 Biologics companies received 11 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 34.4% of all inspections in the first quarter of 2024.

Of all the Tennessee companies involved in the Biologics sector, Center for Reproductive Health Fertility Laboratory of Nashville received the most citations from the FDA in the first 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.

Top 10 FDA Inspections by Number of Actions Indicated in Tennessee During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products9----
Compliance: Devices1----
Drug Quality Assurance1----
Food Composition, Standards, Labeling and Econ2----
Foodborne Biological Hazards95--
Human Cellular, Tissue, and Gene Therapies31--
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics1----

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