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Shelby Reporter

Saturday, November 23, 2024

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

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

There were 42 companies in cities associated with Shelby County, Tennessee, that received 42 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 13.5% increase over the number of companies inspected in the previous year, when 37 companies were inspected through 37 inspections.

Most of the companies inspected were involved in the Food/Cosmetics sector. The second most common type of company inspected in the time period worked in the Devices sector.

There were 32 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (76.2%). Eight should take voluntary action to correct the organization's management operations (19%). Additionally, two companies had to take regulatory and/or administrative actions (4.8%).

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
AB Mauri Foods, Inc.Food/Cosmetics02/10/2023Voluntary Action Indicated (VAI)
ADMFood/Cosmetics07/12/2023No Action Indicated (NAI)
Amar J. Gajjar, M.D.Drugs07/21/2023No Action Indicated (NAI)
American Snuff Company - Memphis, LLCTobacco03/15/2023No Action Indicated (NAI)
Beale Street Landing DockFood/Cosmetics12/27/2023Voluntary Action Indicated (VAI)
Bionova Medical, Inc.Devices09/29/2023No Action Indicated (NAI)
CE-Bio, LLCFood/Cosmetics12/06/2023Voluntary Action Indicated (VAI)
Central States Foods, Inc.Food/Cosmetics05/25/2023Voluntary Action Indicated (VAI)
Charles River Laboratories, Inc.Biologics11/17/2023No Action Indicated (NAI)
Charlie Sciara & Son Produce Company, Inc.Food/Cosmetics03/14/2023No Action Indicated (NAI)
Community Blood CenterBiologics08/02/2023No Action Indicated (NAI)
Convatec Triad Life Sciences, LLCDevices08/24/2023No Action Indicated (NAI)
Cornerstone Laboratories, LLCDrugs01/19/2023Official Action Indicated (OAI)
Creative Testing SolutionsBiologics09/26/2023No Action Indicated (NAI)
Edge Biologicals, Inc.Devices04/04/2023Official Action Indicated (OAI)
El Terrifico, LLCFood/Cosmetics10/31/2023No Action Indicated (NAI)
Engineered Medical Systems, LLCDevices02/10/2023Voluntary Action Indicated (VAI)
Equine Science CompanyVeterinary11/15/2023No Action Indicated (NAI)
Franklin BakerFood/Cosmetics12/22/2023No Action Indicated (NAI)
Hemostatix Medical Technologies, LLCDevices05/02/2023No Action Indicated (NAI)
Hollywood Feed, LLCVeterinary11/29/2023No Action Indicated (NAI)
Le Bonheur Children's Medical CenterBiologics04/27/2023No Action Indicated (NAI)
M. Palazola Produce CompanyFood/Cosmetics04/04/2023No Action Indicated (NAI)
Matrix Machining Technologies, Inc.Devices01/26/2023Voluntary Action Indicated (VAI)
Mckesson Medical and Surgical/Physician Sales & ServiceFood/Cosmetics03/15/2023No Action Indicated (NAI)
MicroPort Orthopedics, Inc.Devices02/08/2023No Action Indicated (NAI)
Natureplex, LLCFood/Cosmetics06/06/2023No Action Indicated (NAI)
Octapharma Plasma, Inc.Biologics03/09/2023No Action Indicated (NAI)
Odyssey Medical Technologies, LLC.Devices04/03/2023Voluntary Action Indicated (VAI)
Somavac Medical Solutions, Inc.Devices09/22/2023Voluntary Action Indicated (VAI)
Specialty Feeds, Inc.Food/Cosmetics08/17/2023No Action Indicated (NAI)
Specialty Feeds, Inc.Veterinary08/17/2023No Action Indicated (NAI)
SpinalGraft Technologies, LLCBiologics06/14/2023No Action Indicated (NAI)
St. Jude Children's Research Hospital Blood BankBiologics02/10/2023No Action Indicated (NAI)
Sterilization Services of Tennessee, Inc.Devices03/02/2023No Action Indicated (NAI)
Stetrix, Inc.Devices11/17/2023No Action Indicated (NAI)
Surface Dynamics, LLCDevices09/21/2023No Action Indicated (NAI)
Tennessee Blood Services CorporationBiologics01/12/2023No Action Indicated (NAI)
The Kellogg CompanyFood/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)
Wilson Air Center MEM, LLCFood/Cosmetics02/21/2023No Action Indicated (NAI)

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