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Friday, November 8, 2024

Washington: Biologics companies were the second least FDA inspected companies in Washington in Q2 2023

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

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

This was the second lowest number of inspections per type of company made by the FDA in Washington, equalling 3.4% of all inspections in the second quarter of 2023.

Of all the Washington companies involved in the Biologics sector, Blood Bank Computer Systems, 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 Washington During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products--2--
Compliance: Devices13--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ7----
Foodborne Biological Hazards258--
Monitoring of Marketed Animal Drugs, Feed, and Devices12--
Postmarket Assurance: Devices31--
Technical Assistance: Food and Cosmetics16----
Tobacco Post-Market Activities----1

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