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Thursday, November 21, 2024

FDA Inspection: What type of Pennsylvania companies were under most scrutiny during Q2 2023?

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In the second quarter of 2023, 47 Food and Cosmetics companies received 47 FDA inspections in Pennsylvania, according to the U.S. Food and Drug Administration (FDA).

This was the highest number of inspections per type of company made by the FDA in Pennsylvania, equalling 50% of all inspections in the second quarter of 2023.

Of all the Pennsylvania companies involved in the Food and Cosmetics sector, American Softgels, Inc. received the most citations from the FDA in the second 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 Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring6----
Blood and Blood Products10----
Compliance: Devices4----
Drug Quality Assurance331
Food Composition, Standards, Labeling and Econ112--
Foodborne Biological Hazards394--
Human Cellular, Tissue, and Gene Therapies5----
Monitoring of Marketed Animal Drugs, Feed, and Devices137--
Technical Assistance: Food and Cosmetics3----
Vaccines and Allergenic Products2----

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