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Palmetto State News

Monday, December 23, 2024

South Carolina: Biologics companies were the second most FDA inspected companies in South Carolina in 2023

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In 2023, 27 Biologics companies received 27 FDA inspections in South Carolina, 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 South Carolina, equalling 33.8% of all inspections in 2023.

Of all the South Carolina companies involved in the Biologics sector, American National Red Cross received the most citations from the FDA in 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 South Carolina During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring5----
Blood and Blood Products231--
Compliance: Devices32--
Drug Quality Assurance--3--
Food Composition, Standards, Labeling and Econ223--
Foodborne Biological Hazards2610--
Human Cellular, Tissue, and Gene Therapies5----
Monitoring of Marketed Animal Drugs, Feed, and Devices21--
Postmarket Assurance: Devices4----
Vaccines and Allergenic Products18----