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Saturday, November 23, 2024

FDA conducted lowest number of inspections on Biologics companies in Massachusetts during Q4 2023

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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 fourth quarter of 2023, two Biologics companies received two FDA inspections in Massachusetts, according to the U.S. Food and Drug Administration (FDA).

This was the lowest number of inspections per type of company made by the FDA in Massachusetts, equalling 6.3% of all inspections in the fourth quarter of 2023.

Of all the Massachusetts companies involved in the Biologics sector, Brammer Bio MA, LLC received the most citations from the FDA 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.

Top 10 FDA Inspections by Number of Actions Indicated in Massachusetts During Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring6----
Compliance: Devices13--
Drug Quality Assurance2----
Food Composition, Standards, Labeling and Econ2----
Foodborne Biological Hazards105--
Human Cellular, Tissue, and Gene Therapies--1--
Monitoring of Marketed Animal Drugs, Feed, and Devices2----
Postmarket Assurance: Devices3----
Radiation Control and Health Safety Act1----
Technical Assistance: Food and Cosmetics2----

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