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Tuesday, November 5, 2024

FDA conducted lowest number of inspections on Biologics companies in Missouri during Q1 2023

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In the first quarter of 2023, four Biologics companies received four FDA inspections in Missouri, 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 Missouri, equalling 6.3% of all inspections in the first quarter of 2023.

Of all the Missouri companies involved in the Biologics sector, SSM-SLUH, Inc. received the most citations from the FDA 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 Missouri During Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring5----
Blood and Blood Products21--
Compliance: Devices14--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ41--
Foodborne Biological Hazards3411
Monitoring of Marketed Animal Drugs, Feed, and Devices91--
Postmarket Assurance: Devices32--
Technical Assistance: Food and Cosmetics6----
Vaccines and Allergenic Products3----

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