Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is an 11.1% decrease from the number of companies inspected in the previous year, when 45 companies were inspected through 46 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 27 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (67.5%). 13 should take voluntary action to correct the organization's management operations (32.5%). Additionally, one company had to take regulatory and/or administrative actions (2.5%).
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 |
|---|---|---|---|
| Aarthun Enterprises, LLC | Food/Cosmetics | 09/08/2023 | Voluntary Action Indicated (VAI) |
| Bergin Fruit Company, Inc. | Food/Cosmetics | 09/08/2023 | Voluntary Action Indicated (VAI) |
| Blackeye Beverage, LLC | Food/Cosmetics | 06/22/2023 | Voluntary Action Indicated (VAI) |
| Bootstrap Coffee Roasters | Food/Cosmetics | 01/06/2023 | No Action Indicated (NAI) |
| Brenntag Great Lakes, LLC | Food/Cosmetics | 02/01/2023 | No Action Indicated (NAI) |
| CSL Plasma, Inc. | Biologics | 07/13/2023 | No Action Indicated (NAI) |
| Carbon Medical Technologies, Inc. | Devices | 11/02/2023 | No Action Indicated (NAI) |
| Donatelle Plastics, Inc. | Devices | 02/28/2023 | No Action Indicated (NAI) |
| Earth Goods, LLC | Food/Cosmetics | 10/06/2023 | No Action Indicated (NAI) |
| Ermi Gebeya | Food/Cosmetics | 03/10/2023 | Voluntary Action Indicated (VAI) |
| Forage North, LLC | Food/Cosmetics | 04/06/2023 | No Action Indicated (NAI) |
| FreshPoint Bix Produce Company, LLC | Food/Cosmetics | 12/06/2023 | No Action Indicated (NAI) |
| Gaoyoua Bakery, LLC | Food/Cosmetics | 10/25/2023 | Voluntary Action Indicated (VAI) |
| GoTop Medical, Inc. | Devices | 03/24/2023 | No Action Indicated (NAI) |
| Hamro Brand, Inc. | Food/Cosmetics | 06/27/2023 | No Action Indicated (NAI) |
| Hawkins, Inc. | Food/Cosmetics | 08/29/2023 | No Action Indicated (NAI) |
| Hemostasis, LLC | Devices | 02/03/2023 | No Action Indicated (NAI) |
| IntriCon Corporation | Devices | 04/17/2023 | Voluntary Action Indicated (VAI) |
| Jonathon Robert Fielding & Company, Inc. | Tobacco | 05/11/2023 | No Action Indicated (NAI) |
| LTS Therapy Systems, LLC | Devices | 09/20/2023 | No Action Indicated (NAI) |
| Lacteos Mi Chalatenango, Inc. | Food/Cosmetics | 09/27/2023 | Voluntary Action Indicated (VAI) |
| Lacteos Mi Chalatenango, Inc. | Food/Cosmetics | 03/22/2023 | Official Action Indicated (OAI) |
| Land O'Lakes, Inc. | Food/Cosmetics | 11/13/2023 | No Action Indicated (NAI) |
| Land O'Lakes, Inc. | Veterinary | 11/13/2023 | No Action Indicated (NAI) |
| Lions Gift of Sight | Biologics | 12/07/2023 | No Action Indicated (NAI) |
| Lovejoys Bloody Mary Mix | Food/Cosmetics | 01/23/2023 | Voluntary Action Indicated (VAI) |
| Mclean Medical & Scientific, Inc. | Devices | 02/08/2023 | No Action Indicated (NAI) |
| Medtronic, Inc. | Devices | 09/01/2023 | No Action Indicated (NAI) |
| MinnSprouts, LLC | Food/Cosmetics | 05/16/2023 | Voluntary Action Indicated (VAI) |
| Plone Shoun Wholesale, Inc. | Food/Cosmetics | 01/09/2023 | No Action Indicated (NAI) |
| Purina Animal Nutrition | Veterinary | 03/14/2023 | No Action Indicated (NAI) |
| RSP Prodo, LLC | Food/Cosmetics | 06/28/2023 | Voluntary Action Indicated (VAI) |
| Shape Medical Systems, Inc. | Devices | 03/02/2023 | No Action Indicated (NAI) |
| Smiths Medical ASD, Inc. | Devices | 06/09/2023 | Voluntary Action Indicated (VAI) |
| St. Paul Beverage Solutions | Food/Cosmetics | 05/10/2023 | No Action Indicated (NAI) |
| Stellen Medical, LLC | Devices | 10/10/2023 | No Action Indicated (NAI) |
| Tasty Treats and Fancy Sweets | Food/Cosmetics | 01/12/2023 | No Action Indicated (NAI) |
| TeaSource, LLC | Food/Cosmetics | 05/26/2023 | No Action Indicated (NAI) |
| The American National Red Cross | Biologics | 07/28/2023 | No Action Indicated (NAI) |
| Vikings and Goddesses Pie Company | Food/Cosmetics | 06/13/2023 | Voluntary Action Indicated (VAI) |
| Westway Feed Products, LLC | Veterinary | 12/07/2023 | Voluntary Action Indicated (VAI) |
| Zen Baking Company | Food/Cosmetics | 07/20/2023 | No Action Indicated (NAI) |
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