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Wednesday, December 25, 2024

How many companies in cities in Shelby County received FDA inspections in Q2 2023?

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Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

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.

Companies Located in Cities Within Shelby County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
Central States Foods, Inc.Food and Cosmetics05/25/2023Voluntary Action Indicated (VAI)
Edge Biologicals, Inc.Devices04/04/2023Official Action Indicated (OAI)
Hemostatix Medical Technologies, LLCDevices05/02/2023No Action Indicated (NAI)
Le Bonheur Children's Medical CenterBiologics04/27/2023No Action Indicated (NAI)
M. Palazola Produce CompanyFood and Cosmetics04/04/2023No Action Indicated (NAI)
Natureplex, LLCFood and Cosmetics06/06/2023No Action Indicated (NAI)
Odyssey Medical Technologies, LLC.Devices04/03/2023Voluntary Action Indicated (VAI)
SpinalGraft Technologies, LLCBiologics06/14/2023No Action Indicated (NAI)
The Kellogg CompanyFood and Cosmetics06/08/2023No Action Indicated (NAI)
University of Tennessee Health Science Center IRBBiologics06/30/2023No Action Indicated (NAI)
University of Tennessee Health Science Center IRBDevices06/30/2023No Action Indicated (NAI)
University of Tennessee Health Science Center IRBDrugs06/30/2023No Action Indicated (NAI)
Veterans Affairs Medical CenterBiologics04/11/2023No Action Indicated (NAI)
VitalantBiologics05/11/2023No Action Indicated (NAI)

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