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Monday, November 4, 2024

Michigan: Biologics companies were the second most FDA inspected companies in Michigan in Q2 2023

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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 2023, eight Biologics companies received eight 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 15.1% of all inspections in the second quarter of 2023.

Of all the Michigan companies involved in the Biologics sector, Pharmacia & Upjohn Company, LLC received the most citations from the FDA in the second 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 Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring23--
Blood and Blood Products52--
Compliance: Devices22--
Drug Quality Assurance121
Food Composition, Standards, Labeling and Econ61--
Foodborne Biological Hazards1011--
Human Cellular, Tissue, and Gene Therapies--2--
Monitoring of Marketed Animal Drugs, Feed, and Devices2----
Postmarket Assurance: Devices31--
Technical Assistance: Food and Cosmetics6----

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