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Thursday, November 14, 2024

Maine: Biologics companies were the second most FDA inspected companies in Maine in 2023

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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 2023, four Biologics companies received four FDA inspections in Maine, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Maine, equalling 7.1% of all inspections in 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.

FDA Inspections in Maine During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products3----
Compliance: Devices2----
Food Composition, Standards, Labeling and Econ12--
Foodborne Biological Hazards3611--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices11--
Postmarket Assurance: Devices2----
Technical Assistance: Food and Cosmetics6----
Vaccines and Allergenic Products4----

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