FDA carried out the second most inspections of biologics companies in Pennsylvania in March

Melanie Keller, Deputy Commissioner for Operations and Chief Operating Officer of FDA
Melanie Keller, Deputy Commissioner for Operations and Chief Operating Officer of FDA
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During March, the FDA inspected six biologics companies across Pennsylvania, according to the U.S. Food and Drug Administration (FDA).

These inspections represented the second-largest share of FDA visits by company type in Pennsylvania, accounting for 20.7% of all inspections conducted that month.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.

FDA Inspections in Pennsylvania During March
Project Area No Action Indicated Voluntary Action Indicated Official Action Indicated
Blood and Blood Products 5 — —
Compliance: Devices 1 3 —
Drug Quality Assurance 1 — —
Food Composition, Standards, Labeling and Econ 5 — —
Foodborne Biological Hazards 13 3 —
Human Cellular, Tissue, and Gene Therapies 1 — —
Postmarket Assurance: Devices 1 1 —
Technical Assistance: Food and Cosmetics 2 — —

Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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