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Monday, November 4, 2024

FDA conducted third highest number of inspections on Biologics companies in Michigan during Q1 2023

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Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

In the first quarter of 2023, three Biologics companies received three FDA inspections in Michigan, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in Michigan, equalling 8.1% of all inspections in the first 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.

Top 10 FDA Inspections by Number of Actions Indicated in Michigan During Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products3----
Compliance: Devices22--
Drug Quality Assurance--11
Food Composition, Standards, Labeling and Econ532
Foodborne Biological Hazards910--
Monitoring of Marketed Animal Drugs, Feed, and Devices----1
Postmarket Assurance: Devices2----
Technical Assistance: Food and Cosmetics3----
Vaccines and Allergenic Products3----

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