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Monday, December 23, 2024

FDA conducted third highest number of inspections on device companies in South Carolina during Q1 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 the first 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 6.7% of all inspections in the first quarter of 2023.

Of all the South Carolina companies involved in the device sector, Carolina Sports and Orthopedics Sales, Inc. received the most citations from the FDA in the first 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 Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products11----
Colors and Cosmetics Technology1----
Compliance: Devices--1--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ53--
Foodborne Biological Hazards93--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Vaccines and Allergenic Products11----

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