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Wednesday, November 6, 2024

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

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Vid Desai FDA’s Chief Information Officer | Official Website

Vid Desai FDA’s Chief Information Officer | Official Website

In April, two Biologics companies received two 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 22.2% of all inspections in April.

Of all the Pennsylvania companies involved in Biologics, Society Hill Reproductive Medicine received the most citations from the FDA in April.

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 April
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products2----
Compliance: Devices1----
Food Composition, Standards, Labeling and Econ1----
Foodborne Biological Hazards31--
Human Cellular, Tissue, and Gene Therapies11--
Monitoring of Marketed Animal Drugs, Feed, and Devices--1--
Postmarket Assurance: Devices11--

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