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Thursday, November 21, 2024

Massachusetts: Device companies were the second most FDA inspected companies in Massachusetts in Q1 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 the first quarter of 2023, eight device companies received eight 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 19.5% of all inspections in the first quarter of 2023.

Of all the Massachusetts companies involved in the device sector, Barrett Technology, LLC received the most citations from the FDA in the first 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 Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring31--
Compliance: Devices15--
Drug Quality Assurance121
Food Composition, Standards, Labeling and Econ2----
Foodborne Biological Hazards178--
Monitoring of Marketed Animal Drugs, Feed, and Devices--1--
Postmarket Assurance: Devices5----
Radiation Control and Health Safety Act--1--
Technical Assistance: Food and Cosmetics2----
Unapproved and Misbranded Drugs----1

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