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Saturday, November 2, 2024

Michigan: Biologics companies were the second most FDA inspected companies in Michigan in Q1

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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 first quarter of 2024, 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 9.5% of all inspections in the first 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 Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products1----
Compliance: Devices--1--
Food Composition, Standards, Labeling and Econ3----
Foodborne Biological Hazards112--
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics6----
Vaccines and Allergenic Products--1--

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