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Saturday, November 2, 2024

Pennsylvania: Biologics companies were the third least FDA inspected companies in Pennsylvania in Q1 2023

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In the first quarter of 2023, seven Biologics companies received seven FDA inspections in Pennsylvania, according to the U.S. Food and Drug Administration (FDA).

This was the third lowest number of inspections per type of company made by the FDA in Pennsylvania, equalling 8.9% of all inspections in the first quarter of 2023.

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 Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring81--
Blood and Blood Products5----
Compliance: Devices31--
Drug Quality Assurance421
Food Composition, Standards, Labeling and Econ102--
Foodborne Biological Hazards327--
Human Cellular, Tissue, and Gene Therapies4----
Monitoring of Marketed Animal Drugs, Feed, and Devices75--
Technical Assistance: Food and Cosmetics4----
Vaccines and Allergenic Products5----

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