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Thursday, November 21, 2024

Oklahoma: Biologics companies were the second least FDA inspected companies in Oklahoma in Q3 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 third quarter of 2023, five Biologics companies received five FDA inspections in Oklahoma, 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 Oklahoma, equalling 13.5% of all inspections in the third 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.

FDA Inspections in Oklahoma During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring11--
Blood and Blood Products3----
Compliance: Devices--1--
Food Composition, Standards, Labeling and Econ--1--
Foodborne Biological Hazards104--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices71--
Postmarket Assurance: Devices--1--
Technical Assistance: Food and Cosmetics8----

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