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Monday, December 23, 2024

South Carolina: Device companies were the third most FDA inspected companies in South Carolina in Q4 2023

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

In the fourth quarter of 2023, two device companies received two FDA inspections in South Carolina, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in South Carolina, equalling 13.3% of all inspections in the fourth 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 South Carolina During Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products11--
Compliance: Devices2----
Drug Quality Assurance--2--
Food Composition, Standards, Labeling and Econ2----
Foodborne Biological Hazards42--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices--1--
Postmarket Assurance: Devices1----
Tobacco Post-Market Activities1----

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