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Wednesday, October 16, 2024

FDA conducted second lowest number of inspections on Drugs companies in Massachusetts during Q1 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 first quarter of 2023, six Drugs companies received six FDA inspections in Massachusetts, according to the U.S. Food and Drug Administration (FDA).

This was the second lowest number of inspections per type of company made by the FDA in Massachusetts, equalling 14.6% of all inspections in the first quarter of 2023.

Of all the Massachusetts companies involved in the Drugs sector, Safecor Health, 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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