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Tuesday, November 5, 2024

FDA Inspection: What type of South Carolina companies were under most scrutiny during Q2 2023?

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

In the second quarter of 2023, 11 Biologics companies received 11 FDA inspections in South Carolina, according to the U.S. Food and Drug Administration (FDA).

This was the highest number of inspections per type of company made by the FDA in South Carolina, equalling 57.9% of all inspections in the second 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.

FDA Inspections in South Carolina During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products11----
Compliance: Devices--1--
Food Composition, Standards, Labeling and Econ5----
Foodborne Biological Hazards52--
Human Cellular, Tissue, and Gene Therapies2----
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics--1--
Vaccines and Allergenic Products7----

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