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Thursday, November 7, 2024

South Carolina: Biologics companies were the second most FDA inspected companies in South Carolina in Q1

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

In the first quarter of 2024, six Biologics companies received six 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 31.6% of all inspections 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 South Carolina During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products5----
Compliance: Devices1----
Drug Quality Assurance----1
Food Composition, Standards, Labeling and Econ2----
Foodborne Biological Hazards43--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Postmarket Assurance: Devices1----
Tobacco Post-Market Activities--1--

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