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Minnesota State Wire

Monday, November 4, 2024

FDA conducted lowest number of inspections on Biologics companies in Minnesota during Q4 2023

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

In the fourth quarter of 2023, one Biologics company received an FDA inspection in Minnesota, according to the U.S. Food and Drug Administration (FDA).

This was the lowest number of inspections per type of company made by the FDA in Minnesota, equalling 1.8% 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.

FDA Inspections in Minnesota During Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products1----
Compliance: Devices21--
Drug Quality Assurance11--
Food Composition, Standards, Labeling and Econ1----
Foodborne Biological Hazards184--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices65--
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics16----

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