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Wednesday, April 23, 2025

South Carolina: Biologics companies were the second most FDA inspected companies in South Carolina in 2024

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

In 2024, 14 Biologics companies received 14 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 15.2% of all inspections in 2024.

Of all the South Carolina companies involved in the Biologics sector, Specialty Blood Center received the most citations from the FDA in 2024.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality.

Top 10 FDA Inspections by Number of Actions Indicated in South Carolina During 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring91
Blood and Blood Products92
Compliance: Devices24
Drug Quality Assurance111
Food Composition, Standards, Labeling and Econ152
Foodborne Biological Hazards36121
Human Cellular, Tissue, and Gene Therapies11
Monitoring of Marketed Animal Drugs, Feed, and Devices42
Postmarket Assurance: Devices22
Technical Assistance: Food and Cosmetics4

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