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Minnesota State Wire

Monday, November 4, 2024

Minnesota: Device companies were the second most FDA inspected companies in Minnesota in Q1

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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 first quarter of 2024, 13 device companies received 13 FDA inspections in Minnesota, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Minnesota, equalling 26% of all inspections in the first quarter of 2024.

Of all the Minnesota companies involved in the device sector, Medspira, LLC received the most citations from the FDA in the first quarter of 2024.

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 Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products2----
Colors and Cosmetics Technology--1--
Compliance: Devices67--
Drug Quality Assurance1----
Food Composition, Standards, Labeling and Econ21--
Foodborne Biological Hazards125--
Monitoring of Marketed Animal Drugs, Feed, and Devices32--
Postmarket Assurance: Devices42--
Technical Assistance: Food and Cosmetics9----

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