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Thursday, November 21, 2024

FDA conducted third highest number of inspections on Drugs companies in Massachusetts during 2023

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

In 2023, 26 Drugs companies received 27 FDA inspections in Massachusetts, 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 Massachusetts, equalling 14.8% of all inspections in 2023.

Of all the Massachusetts companies involved in the Drugs sector, Lohxa, LLC received the most citations from the FDA in 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 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring262--
Blood and Blood Products71--
Compliance: Devices7176
Drug Quality Assurance642
Food Composition, Standards, Labeling and Econ4----
Foodborne Biological Hazards58301
Human Cellular, Tissue, and Gene Therapies43--
Monitoring of Marketed Animal Drugs, Feed, and Devices32--
Postmarket Assurance: Devices1342
Technical Assistance: Food and Cosmetics71--

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