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Wednesday, November 6, 2024

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

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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 January, 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 9.1% of all inspections in January.

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 January
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products2----
Compliance: Devices--1--
Drug Quality Assurance--3--
Food Composition, Standards, Labeling and Econ3----
Foodborne Biological Hazards101--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices31--
Postmarket Assurance: Devices--1--
Radiation Control and Health Safety Act--1--

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