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Monday, May 20, 2024

Pennsylvania: Biologics companies were the second least FDA inspected companies in Pennsylvania in Q3 2023

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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 the third quarter of 2023, 10 Biologics companies received 10 FDA inspections in Pennsylvania, 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 Pennsylvania, equalling 10% of all inspections 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 Pennsylvania During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring31--
Blood and Blood Products9----
Compliance: Devices51--
Drug Quality Assurance12--
Food Composition, Standards, Labeling and Econ162--
Foodborne Biological Hazards4313--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices105--
Postmarket Assurance: Devices11--
Technical Assistance: Food and Cosmetics6----

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