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Sunday, November 24, 2024

FDA conducted second lowest number of inspections on Biologics companies in South Dakota during Q2 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 second quarter of 2023, three Biologics companies received three FDA inspections in South Dakota, according to the U.S. Food and Drug Administration (FDA).

This was the second lowest number of inspections per type of company made by the FDA in South Dakota, equalling 15% 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 Dakota During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products2----
Compliance: Devices1----
Food Composition, Standards, Labeling and Econ--1--
Foodborne Biological Hazards22--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices92--
Postmarket Assurance: Devices1----
Tobacco Post-Market Activities1----

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