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Wednesday, September 10, 2025

Michigan: Biologics companies were the second most FDA inspected companies in Michigan in Q2

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In the second quarter of 2025, four Biologics companies received four FDA inspections in Michigan, 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 Michigan, equalling 16% of all inspections in the second quarter of 2025.

Of all the Michigan companies involved in the Biologics sector, Versiti Michigan, Inc. received the most citations from the FDA in the second quarter of 2025.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality.

FDA Inspections in Michigan During Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products11
Compliance: Devices2
Drug Quality Assurance21
Food Composition, Standards, Labeling and Econ32
Foodborne Biological Hazards53
Human Cellular, Tissue, and Gene Therapies2
Monitoring of Marketed Animal Drugs, Feed, and Devices31
Postmarket Assurance: Devices11
Technical Assistance: Food and Cosmetics1

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