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Thursday, April 24, 2025

Pennsylvania: Biologics companies were the second most FDA inspected companies in Pennsylvania in 2024

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

In 2024, 56 Biologics companies received 56 FDA inspections in Pennsylvania, 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 Pennsylvania, equalling 16.3% of all inspections in 2024.

Of all the Pennsylvania companies involved in the Biologics sector, Corixa Corporation and Eclipse Technology Solutions, Inc. received the most citations from the FDA in 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.

Top 10 FDA Inspections by Number of Actions Indicated in Pennsylvania During 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring385
Blood and Blood Products37
Compliance: Devices136
Drug Quality Assurance482
Food Composition, Standards, Labeling and Econ463
Foodborne Biological Hazards125302
Human Cellular, Tissue, and Gene Therapies133
Monitoring of Marketed Animal Drugs, Feed, and Devices3911
Postmarket Assurance: Devices25
Technical Assistance: Food and Cosmetics17

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