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Saturday, May 4, 2024

Rhode Island: Biologics companies were the second most FDA inspected companies in Rhode Island 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 Rhode Island, 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 Rhode Island, equalling 28.6% 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 Rhode Island During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring5----
Blood and Blood Products3----
Compliance: Devices--1--
Foodborne Biological Hazards4----
Human Cellular, Tissue, and Gene Therapies2----
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics21--
Vaccines and Allergenic Products1----

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