James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is a 43.8% decrease from the number of companies inspected in the previous year, when 48 companies received 51 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 (74.1%). Six should take voluntary action to correct the organization's management operations (22.2%). Additionally, one company had to take regulatory and/or administrative actions (3.7%).
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 |
|---|---|---|---|
| Accupack Midwest, Inc. | Drugs | 02/27/2024 | Official Action Indicated (OAI) |
| Asad Wholesale, Inc. | Food and Cosmetics | 07/09/2024 | No Action Indicated (NAI) |
| B. C. C. Direct, LLC | Food and Cosmetics | 06/10/2024 | No Action Indicated (NAI) |
| Complete, M.D. | Food and Cosmetics | 05/28/2024 | No Action Indicated (NAI) |
| Dystar Hilton Davis Corporation | Food and Cosmetics | 06/20/2024 | No Action Indicated (NAI) |
| Ebner Medical, LLC | Devices | 08/05/2024 | No Action Indicated (NAI) |
| Elite Biomedical Solutions, LLC | Devices | 05/10/2024 | No Action Indicated (NAI) |
| Fresh Food ToGo, Inc. | Food and Cosmetics | 09/12/2024 | No Action Indicated (NAI) |
| Hoxworth Blood Center UC Medical Center | Biologics | 06/04/2024 | No Action Indicated (NAI) |
| Hoxworth Blood Center University of Cincinnati | Biologics | 04/10/2024 | No Action Indicated (NAI) |
| I-Heal Company, LLC | Devices | 09/10/2024 | No Action Indicated (NAI) |
| M&B Distributors, Inc. | Food and Cosmetics | 09/10/2024 | No Action Indicated (NAI) |
| Medpace, Inc. | Drugs | 03/06/2024 | No Action Indicated (NAI) |
| Medpace, Inc. | Drugs | 07/11/2024 | No Action Indicated (NAI) |
| Megadyne Medical Products, Inc. | Devices | 11/22/2024 | No Action Indicated (NAI) |
| Nitto Denko Avecia, Inc. | Drugs | 08/20/2024 | No Action Indicated (NAI) |
| Octapharma Plasma, Inc. | Biologics | 01/10/2024 | Voluntary Action Indicated (VAI) |
| Peter Cremer North America LP | Food and Cosmetics | 05/10/2024 | No Action Indicated (NAI) |
| Rocket Systems, Inc. | Food and Cosmetics | 06/26/2024 | No Action Indicated (NAI) |
| The Christ Hospital Health Network | Biologics | 07/02/2024 | No Action Indicated (NAI) |
| The Gorilla Glue Company | Drugs | 02/23/2024 | Voluntary Action Indicated (VAI) |
| The Kroger Company | Food and Cosmetics | 03/19/2024 | Voluntary Action Indicated (VAI) |
| The Kroger Company | Food and Cosmetics | 01/10/2024 | Voluntary Action Indicated (VAI) |
| Tobu Corporation | Food and Cosmetics | 04/18/2024 | Voluntary Action Indicated (VAI) |
| TriHealth IRB | Biologics | 04/18/2024 | No Action Indicated (NAI) |
| TriHealth IRB | Devices | 04/18/2024 | No Action Indicated (NAI) |
| TriHealth IRB | Drugs | 04/18/2024 | No Action Indicated (NAI) |
| United Dairy Farmers, Inc. | Food and Cosmetics | 12/23/2024 | Voluntary Action Indicated (VAI) |
| Urban Stead Cheese, LLC | Food and Cosmetics | 11/21/2024 | No Action Indicated (NAI) |
| Vein360, LLC | Devices | 01/08/2024 | No Action Indicated (NAI) |
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