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Friday, November 8, 2024

Washington: Biologics companies were the second most FDA inspected companies in Washington in Q1 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 first quarter of 2023, eight Biologics companies received eight FDA inspections in Washington, 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 Washington, equalling 11.1% of all inspections in the first 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 Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products7----
Colors and Cosmetics Technology--1--
Compliance: Devices--1--
Food Composition, Standards, Labeling and Econ56--
Foodborne Biological Hazards3410--
Human Cellular, Tissue, and Gene Therapies6----
Monitoring of Marketed Animal Drugs, Feed, and Devices2----
Technical Assistance: Food and Cosmetics161--
Vaccines and Allergenic Products7----

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