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Monday, May 20, 2024

FDA conducted second lowest number of inspections on Drugs companies in Massachusetts during Q3 2023

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

In the third quarter of 2023, five Drugs companies received five 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 7.6% of all inspections in the third quarter of 2023.

Of all the Massachusetts companies involved in the Drugs sector, Lohxa, LLC received the most citations from the FDA in the third 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 Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring51--
Blood and Blood Products71--
Compliance: Devices454
Drug Quality Assurance----1
Foodborne Biological Hazards209--
Human Cellular, Tissue, and Gene Therapies42--
Monitoring of Marketed Animal Drugs, Feed, and Devices11--
Postmarket Assurance: Devices431
Technical Assistance: Food and Cosmetics3----
Vaccines and Allergenic Products--3--

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