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Wednesday, November 27, 2024

Pennsylvania: Biologics companies were the third most FDA inspected companies in Pennsylvania in Q1

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In the first quarter of 2024, eight Biologics companies received eight FDA inspections in Pennsylvania, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in Pennsylvania, equalling 13.6% of all inspections in the first quarter of 2024.

Of all the Pennsylvania companies involved in the Biologics sector, Corixa Corporation received the most citations from the FDA in the first 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.

Top 10 FDA Inspections by Number of Actions Indicated in Pennsylvania During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring6----
Blood and Blood Products6----
Colors and Cosmetics Technology1----
Compliance: Devices24--
Drug Quality Assurance--3--
Food Composition, Standards, Labeling and Econ10----
Foodborne Biological Hazards203--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices83--
Postmarket Assurance: Devices--3--

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