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Tuesday, April 22, 2025

Massachusetts: Devices companies were the least FDA inspected companies in Massachusetts in March

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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 March, two Devices companies received two FDA inspections in Massachusetts, according to the U.S. Food and Drug Administration (FDA).

This was the lowest number of inspections per type of company made by the FDA in Massachusetts, equalling 33.3% of all inspections in March.

Of all the Massachusetts companies involved in Devices, Saphena Medical, Inc. received the most citations from the FDA in March.

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 March
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Compliance: Devices11
Food Composition, Standards, Labeling and Econ1
Foodborne Biological Hazards4
Postmarket Assurance: Devices11

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