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Thursday, November 21, 2024

FDA Inspection: What type of Tennessee companies were under most scrutiny during September?

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

In September, three Biologics companies received three FDA inspections in Tennessee, according to the U.S. Food and Drug Administration (FDA).

This was the highest number of inspections per type of company made by the FDA in Tennessee, equalling 37.5% of all inspections in September.

Of all the Tennessee companies involved in Biologics, Fertility Center, LLC received the most citations from the FDA in September.

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 Tennessee During September
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Foodborne Biological Hazards3----
Human Cellular, Tissue, and Gene Therapies21--
Monitoring of Marketed Animal Drugs, Feed, and Devices2----
Technical Assistance: Food and Cosmetics1----

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