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Monday, December 23, 2024

Michigan: Biologics companies were the second most FDA inspected companies in Michigan in Q4 2023

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

In the fourth quarter of 2023, two Biologics companies received two 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 6.9% of all inspections in the fourth 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.

FDA Inspections in Michigan During Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products1----
Compliance: Devices1----
Food Composition, Standards, Labeling and Econ411
Foodborne Biological Hazards115--
Monitoring of Marketed Animal Drugs, Feed, and Devices11--
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics5----

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