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Monday, November 4, 2024

FDA conducted second lowest number of inspections on Biologics companies in Michigan during Q2

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

In the second quarter of 2024, four Biologics companies received four FDA inspections in Michigan, 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 Michigan, equalling 14.8% of all inspections in the second 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.

FDA Inspections in Michigan During Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products2----
Compliance: Devices--1--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ--1--
Foodborne Biological Hazards73--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices311
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics7----

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