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Tuesday, December 17, 2024

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

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In the third quarter of 2024, five Biologics companies received five FDA inspections in Massachusetts, 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 Massachusetts, equalling 29.4% of all inspections 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 Massachusetts During Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring--1--
Blood and Blood Products2----
Compliance: Devices--1--
Drug Quality Assurance----1
Foodborne Biological Hazards62--
Human Cellular, Tissue, and Gene Therapies3----
Postmarket Assurance: Devices--1--
Technical Assistance: Food and Cosmetics--1--

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