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Tuesday, November 5, 2024

Pennsylvania: Device companies were the second least FDA inspected companies in Pennsylvania in Q2

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Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

In the second quarter of 2024, three device companies received three 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 9.7% of all inspections 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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