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Saturday, November 23, 2024

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

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In the second quarter of 2023, 16 Biologics companies received 16 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 22.5% of all inspections in the second quarter of 2023.

Of all the Georgia companies involved in the Biologics sector, LifeSouth Community Blood Centers, Inc. received the most citations from the FDA 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.

Top 10 FDA Inspections by Number of Actions Indicated in Georgia During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring5----
Blood and Blood Products131--
Colors and Cosmetics Technology1----
Compliance: Devices--2--
Drug Quality Assurance1--2
Food Composition, Standards, Labeling and Econ81--
Foodborne Biological Hazards3041
Human Cellular, Tissue, and Gene Therapies3----
Technical Assistance: Food and Cosmetics5----
Vaccines and Allergenic Products2----

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