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Minnesota State Wire

Monday, December 23, 2024

Minnesota: Device companies were the third most FDA inspected companies in Minnesota in Q3 2023

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

In the third quarter of 2023, four device companies received four FDA inspections in Minnesota, 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 Minnesota, equalling 5.3% of all inspections in the third quarter of 2023.

Of all the Minnesota companies involved in the device sector, Culligan Soft Water Service Company received the most citations from the FDA in the third 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 Minnesota During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products4----
Compliance: Devices21--
Drug Quality Assurance--21
Food Composition, Standards, Labeling and Econ23--
Foodborne Biological Hazards2516--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices321
Postmarket Assurance: Devices3----
Technical Assistance: Food and Cosmetics15----

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