FDA reports third lowest biologics company inspection count in Pennsylvania for 2025

Sara Brenner, Principal Deputy Commissioner at FDA
Sara Brenner, Principal Deputy Commissioner at FDA
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The FDA conducted 55 inspections at biologics firms in Pennsylvania during 2025, according to the U.S. Food and Drug Administration (FDA).

These inspections represented the third lowest count among different company types inspected by the FDA in Pennsylvania, accounting for 9.5% of all inspections that year.

Among Pennsylvania’s biologics companies, A Plus Phlebotomy Services received the highest number of FDA citations in 2025.

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 and quality.

Top 10 FDA Inspections by Number of Actions Indicated in Pennsylvania During 2025
Project Area No Action Indicated Voluntary Action Indicated Official Action Indicated
Bioresearch Monitoring 44 5 —
Blood and Blood Products 26 5 —
Compliance: Devices 21 7 1
Drug Quality Assurance 14 22 6
Food Composition, Standards, Labeling and Econ 86 3 1
Foodborne Biological Hazards 262 45 1
Human Cellular, Tissue, and Gene Therapies 14 2 —
Monitoring of Marketed Animal Drugs, Feed, and Devices 47 27 —
Postmarket Assurance: Devices 7 3 —
Technical Assistance: Food and Cosmetics 26 1 —

Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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