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
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.
Company Name | Area of Business | Inspection Date | Result |
---|---|---|---|
AB Mauri Foods, Inc. | Food/Cosmetics | 02/10/2023 | Voluntary Action Indicated (VAI) |
ADM | Food/Cosmetics | 07/12/2023 | No Action Indicated (NAI) |
Amar J. Gajjar, M.D. | Drugs | 07/21/2023 | No Action Indicated (NAI) |
American Snuff Company - Memphis, LLC | Tobacco | 03/15/2023 | No Action Indicated (NAI) |
Beale Street Landing Dock | Food/Cosmetics | 12/27/2023 | Voluntary Action Indicated (VAI) |
Bionova Medical, Inc. | Devices | 09/29/2023 | No Action Indicated (NAI) |
CE-Bio, LLC | Food/Cosmetics | 12/06/2023 | Voluntary Action Indicated (VAI) |
Central States Foods, Inc. | Food/Cosmetics | 05/25/2023 | Voluntary Action Indicated (VAI) |
Charles River Laboratories, Inc. | Biologics | 11/17/2023 | No Action Indicated (NAI) |
Charlie Sciara & Son Produce Company, Inc. | Food/Cosmetics | 03/14/2023 | No Action Indicated (NAI) |
Community Blood Center | Biologics | 08/02/2023 | No Action Indicated (NAI) |
Convatec Triad Life Sciences, LLC | Devices | 08/24/2023 | No Action Indicated (NAI) |
Cornerstone Laboratories, LLC | Drugs | 01/19/2023 | Official Action Indicated (OAI) |
Creative Testing Solutions | Biologics | 09/26/2023 | No Action Indicated (NAI) |
Edge Biologicals, Inc. | Devices | 04/04/2023 | Official Action Indicated (OAI) |
El Terrifico, LLC | Food/Cosmetics | 10/31/2023 | No Action Indicated (NAI) |
Engineered Medical Systems, LLC | Devices | 02/10/2023 | Voluntary Action Indicated (VAI) |
Equine Science Company | Veterinary | 11/15/2023 | No Action Indicated (NAI) |
Franklin Baker | Food/Cosmetics | 12/22/2023 | No Action Indicated (NAI) |
Hemostatix Medical Technologies, LLC | Devices | 05/02/2023 | No Action Indicated (NAI) |
Hollywood Feed, LLC | Veterinary | 11/29/2023 | No Action Indicated (NAI) |
Le Bonheur Children's Medical Center | Biologics | 04/27/2023 | No Action Indicated (NAI) |
M. Palazola Produce Company | Food/Cosmetics | 04/04/2023 | No Action Indicated (NAI) |
Matrix Machining Technologies, Inc. | Devices | 01/26/2023 | Voluntary Action Indicated (VAI) |
Mckesson Medical and Surgical/Physician Sales & Service | Food/Cosmetics | 03/15/2023 | No Action Indicated (NAI) |
MicroPort Orthopedics, Inc. | Devices | 02/08/2023 | No Action Indicated (NAI) |
Natureplex, LLC | Food/Cosmetics | 06/06/2023 | No Action Indicated (NAI) |
Octapharma Plasma, Inc. | Biologics | 03/09/2023 | No Action Indicated (NAI) |
Odyssey Medical Technologies, LLC. | Devices | 04/03/2023 | Voluntary Action Indicated (VAI) |
Somavac Medical Solutions, Inc. | Devices | 09/22/2023 | Voluntary Action Indicated (VAI) |
Specialty Feeds, Inc. | Food/Cosmetics | 08/17/2023 | No Action Indicated (NAI) |
Specialty Feeds, Inc. | Veterinary | 08/17/2023 | No Action Indicated (NAI) |
SpinalGraft Technologies, LLC | Biologics | 06/14/2023 | No Action Indicated (NAI) |
St. Jude Children's Research Hospital Blood Bank | Biologics | 02/10/2023 | No Action Indicated (NAI) |
Sterilization Services of Tennessee, Inc. | Devices | 03/02/2023 | No Action Indicated (NAI) |
Stetrix, Inc. | Devices | 11/17/2023 | No Action Indicated (NAI) |
Surface Dynamics, LLC | Devices | 09/21/2023 | No Action Indicated (NAI) |
Tennessee Blood Services Corporation | Biologics | 01/12/2023 | No Action Indicated (NAI) |
The Kellogg Company | Food/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) |
Wilson Air Center MEM, LLC | Food/Cosmetics | 02/21/2023 | No Action Indicated (NAI) |