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Friday, September 20, 2024

Massachusetts: Biologics companies were the least FDA inspected companies in Massachusetts in Q2

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

In the second quarter of 2024, three Biologics companies received three 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 14.3% of all inspections in the second quarter of 2024.

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.

FDA Inspections in Massachusetts During Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products2----
Compliance: Devices14--
Foodborne Biological Hazards93--
Human Cellular, Tissue, and Gene Therapies2----
Postmarket Assurance: Devices4----
Radiation Control and Health Safety Act--1--
Technical Assistance: Food and Cosmetics1----

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