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Saturday, December 21, 2024

Michigan: Biologics companies were the second most FDA inspected companies in Michigan in Q3

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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 third quarter of 2024, three Biologics companies received three 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 10.7% of all inspections in the third quarter of 2024.

Of all the Michigan companies involved in the Biologics sector, CSL Plasma, Inc. received the most citations from the FDA in the third 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 Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products21--
Compliance: Devices1----
Food Composition, Standards, Labeling and Econ1----
Foodborne Biological Hazards93--
Monitoring of Marketed Animal Drugs, Feed, and Devices2----
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics11----

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