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Maryland State Wire

Monday, April 29, 2024

FDA conducted lowest number of inspections on Biologics companies in Maryland during Q4 2023

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In the fourth quarter of 2023, two Biologics companies received two FDA inspections in Maryland, according to the U.S. Food and Drug Administration (FDA).

This was the lowest number of inspections per type of company made by the FDA in Maryland, equalling 7.7% of all inspections in the fourth quarter of 2023.

Of all the Maryland companies involved in the Biologics sector, Greater Baltimore Medical Center received the most citations from the FDA in the fourth 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 Maryland During Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring2----
Blood and Blood Products11--
Compliance: Devices13--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ71--
Foodborne Biological Hazards651
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices31--
Postmarket Assurance: Devices3----
Technical Assistance: Food and Cosmetics1----

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