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Sunday, December 22, 2024

Georgia: Biologics companies were the second most FDA inspected companies in Georgia in Q1 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 first quarter of 2023, eight Biologics companies received eight FDA inspections in Georgia, 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 Georgia, equalling 14.5% of all inspections in the first quarter of 2023.

Of all the Georgia companies involved in the Biologics sector, MiMedx Group, Inc. received the most citations from the FDA in the first 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 Georgia During Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring5----
Blood and Blood Products7----
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ4----
Foodborne Biological Hazards2012--
Human Cellular, Tissue, and Gene Therapies----1
Monitoring of Marketed Animal Drugs, Feed, and Devices3----
Technical Assistance: Food and Cosmetics5----
Tobacco Post-Market Activities1----
Vaccines and Allergenic Products7----

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