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 22.2% decrease from the number of companies inspected in the previous year, when 45 companies received 45 inspections.
Most of the companies inspected at the time were involved in the Food and Cosmetics sector. The second most common type of company inspected period worked in the Devices sector.
There were 20 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (57.1%). 15 should take voluntary action to correct the organization's management operations (42.9%). Additionally, one company had to take regulatory and/or administrative actions (2.9%).
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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Result |
|---|---|---|---|
| Abeona Therapeutics, Inc. | Biologics | 01/24/2024 | No Action Indicated (NAI) |
| Athens Foods, Inc. | Food and Cosmetics | 12/04/2024 | No Action Indicated (NAI) |
| Azenta US, Inc. | Biologics | 01/29/2024 | No Action Indicated (NAI) |
| Bimbo Bakeries USA, Inc. | Food and Cosmetics | 03/01/2024 | No Action Indicated (NAI) |
| CSL Plasma, Inc. | Biologics | 11/07/2024 | No Action Indicated (NAI) |
| Cleveland Airport System | Food and Cosmetics | 02/26/2024 | Voluntary Action Indicated (VAI) |
| Cleveland Cuyahoga County Port Authority | Food and Cosmetics | 02/15/2024 | Voluntary Action Indicated (VAI) |
| Euro USA, Inc. | Food and Cosmetics | 06/11/2024 | No Action Indicated (NAI) |
| Health-Mor, Inc. | Devices | 06/14/2024 | Voluntary Action Indicated (VAI) |
| Heinen's, Inc. | Food and Cosmetics | 09/24/2024 | No Action Indicated (NAI) |
| Heinen's, Inc. | Food and Cosmetics | 06/17/2024 | No Action Indicated (NAI) |
| Herolds Salads, Inc. | Food and Cosmetics | 12/10/2024 | Voluntary Action Indicated (VAI) |
| Herolds Salads, Inc. | Food and Cosmetics | 01/18/2024 | Official Action Indicated (OAI) |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Voluntary Action Indicated (VAI) |
| I Am Well Holistic, Inc. | Food and Cosmetics | 05/28/2024 | Voluntary Action Indicated (VAI) |
| Kanan Enterprises, Inc. | Food and Cosmetics | 12/17/2024 | No Action Indicated (NAI) |
| Krusinski Family Trust | Food and Cosmetics | 01/03/2024 | No Action Indicated (NAI) |
| Louis Stokes Cleveland VA Medical Center | Biologics | 01/05/2024 | No Action Indicated (NAI) |
| Miceli Dairy Products Company | Food and Cosmetics | 11/21/2024 | No Action Indicated (NAI) |
| Ms Cotti, Inc. | Food and Cosmetics | 11/14/2024 | No Action Indicated (NAI) |
| National Foods Packaging Incorporated | Food and Cosmetics | 08/30/2024 | Voluntary Action Indicated (VAI) |
| Nestle Prepared Foods a Division of Nestle USA | Food and Cosmetics | 09/25/2024 | No Action Indicated (NAI) |
| Norman Noble, Inc. | Devices | 12/19/2024 | Voluntary Action Indicated (VAI) |
| Oakwood Laboratories, LLC | Drugs | 08/13/2024 | Voluntary Action Indicated (VAI) |
| PETNET Solutions Cleveland, LLC | Drugs | 08/09/2024 | No Action Indicated (NAI) |
| Pemco, Inc. | Devices | 10/25/2024 | Voluntary Action Indicated (VAI) |
| Pierre's Ice Cream Company, Inc. | Food and Cosmetics | 05/31/2024 | No Action Indicated (NAI) |
| QR8 Health, Inc. | Devices | 08/19/2024 | No Action Indicated (NAI) |
| R L Lipton Distributing | Food and Cosmetics | 03/18/2024 | No Action Indicated (NAI) |
| Rhinosystems, Inc. | Devices | 02/08/2024 | Voluntary Action Indicated (VAI) |
| T. Marzetti Company | Food and Cosmetics | 03/21/2024 | No Action Indicated (NAI) |
| Technician Industries, Inc. | Devices | 09/03/2024 | Voluntary Action Indicated (VAI) |
| Transdermal Cap, Inc. | Devices | 03/26/2024 | Voluntary Action Indicated (VAI) |
| Viscus Biologics, LLC | Devices | 05/09/2024 | Voluntary Action Indicated (VAI) |
| VisionAir Solutions, LLC | Devices | 03/14/2024 | Voluntary Action Indicated (VAI) |
| William Wiley, M.D. | Devices | 07/19/2024 | No Action Indicated (NAI) |
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