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Tuesday, November 5, 2024

Pennsylvania: Biologics companies were the second most FDA inspected companies in Pennsylvania in Q2

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Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

In the second 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 second highest number of inspections per type of company made by the FDA in Pennsylvania, equalling 25.8% of all inspections in the second quarter of 2024.

Of all the Pennsylvania companies involved in the Biologics sector, Society Hill Reproductive Medicine received the most citations from the FDA 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 Pennsylvania During Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products8----
Compliance: Devices2----
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ2----
Foodborne Biological Hazards124--
Human Cellular, Tissue, and Gene Therapies11--
Monitoring of Marketed Animal Drugs, Feed, and Devices11--
Postmarket Assurance: Devices11--

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