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Wednesday, November 6, 2024

Pennsylvania: Biologics companies were the second least FDA inspected companies in Pennsylvania in March

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

In March, two Biologics companies received two 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 11.8% of all inspections in March.

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 March
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products2----
Compliance: Devices22--
Food Composition, Standards, Labeling and Econ1----
Foodborne Biological Hazards32--
Monitoring of Marketed Animal Drugs, Feed, and Devices41--
Postmarket Assurance: Devices--1--
Technical Assistance: Food and Cosmetics1----

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