Shelby Reporter

There were 12 companies in cities associated with Shelby County, Tennessee, that received 12 FDA inspections in the second quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 7.7% decrease from the number of companies inspected in the previous quarter, when 13 companies received 13 inspections.

Most of the companies inspected at the time were involved in the Biologics sector. Both the Food and Cosmetics and Devices sectors sectors tied for second most common type.

There were nine companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (75%). Two should take voluntary action to correct the organization's management operations (16.7%). Additionally, one company had to take regulatory and/or administrative actions (8.3%).

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Result
Central States Foods, Inc.	Food and Cosmetics	05/25/2023	Voluntary Action Indicated (VAI)
Edge Biologicals, Inc.	Devices	04/04/2023	Official Action Indicated (OAI)
Hemostatix Medical Technologies, LLC	Devices	05/02/2023	No Action Indicated (NAI)
Le Bonheur Children's Medical Center	Biologics	04/27/2023	No Action Indicated (NAI)
M. Palazola Produce Company	Food and Cosmetics	04/04/2023	No Action Indicated (NAI)
Natureplex, LLC	Food and Cosmetics	06/06/2023	No Action Indicated (NAI)
Odyssey Medical Technologies, LLC.	Devices	04/03/2023	Voluntary Action Indicated (VAI)
SpinalGraft Technologies, LLC	Biologics	06/14/2023	No Action Indicated (NAI)
The Kellogg Company	Food and Cosmetics	06/08/2023	No Action Indicated (NAI)
University of Tennessee Health Science Center IRB	Biologics	06/30/2023	No Action Indicated (NAI)
University of Tennessee Health Science Center IRB	Devices	06/30/2023	No Action Indicated (NAI)
University of Tennessee Health Science Center IRB	Drugs	06/30/2023	No Action Indicated (NAI)
Veterans Affairs Medical Center	Biologics	04/11/2023	No Action Indicated (NAI)
Vitalant	Biologics	05/11/2023	No Action Indicated (NAI)