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Tuesday, April 22, 2025

Massachusetts: Device companies were the second most FDA inspected companies in Massachusetts in Q4 2024

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Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

In the fourth quarter of 2024, five device companies received five 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 16.7% of all inspections in the fourth quarter of 2024.

Of all the Massachusetts companies involved in the device sector, Mannkind Corporation received the most citations from the FDA in the fourth quarter of 2024.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality.

FDA Inspections in Massachusetts During Q4 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring21
Blood and Blood Products2
Compliance: Devices131
Drug Quality Assurance1
Foodborne Biological Hazards136
Postmarket Assurance: Devices4

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