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 25% increase over the number of companies inspected in the previous year, when 16 companies were inspected through 20 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 and Drugs sectors.
There were 11 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (55%). Eight should take voluntary action to correct the organization's management operations (40%). Additionally, one company had to take regulatory and/or administrative actions (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 |
---|---|---|---|
Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Voluntary Action Indicated (VAI) |
Americold Logistics | Food/Cosmetics | 07/24/2023 | No Action Indicated (NAI) |
Ampcare, LLC | Devices | 04/26/2023 | No Action Indicated (NAI) |
Bankole Osuntokun, M.D. | Drugs | 11/16/2023 | No Action Indicated (NAI) |
Biscuits & Cookies International | Food/Cosmetics | 08/15/2023 | Voluntary Action Indicated (VAI) |
Danone US, LLC. | Food/Cosmetics | 07/14/2023 | No Action Indicated (NAI) |
Fresh Innovations, LLC | Food/Cosmetics | 08/09/2023 | No Action Indicated (NAI) |
Fruit of the Earth, Inc. | Food/Cosmetics | 10/10/2023 | No Action Indicated (NAI) |
Kerry, Inc. | Food/Cosmetics | 05/04/2023 | No Action Indicated (NAI) |
Lucid Wellness, LLC | Food/Cosmetics | 02/17/2023 | Voluntary Action Indicated (VAI) |
Mibo Fresh Foods, LLC | Food/Cosmetics | 01/09/2023 | No Action Indicated (NAI) |
Mid-States Distributing, LLC | Veterinary | 09/11/2023 | Voluntary Action Indicated (VAI) |
Mtek Group, LLC | Food/Cosmetics | 09/27/2023 | Voluntary Action Indicated (VAI) |
Paul S. Thornton, M.D. | Drugs | 09/15/2023 | No Action Indicated (NAI) |
Premier Produce Services | Food/Cosmetics | 05/02/2023 | Voluntary Action Indicated (VAI) |
Renfro Foods, Inc. | Food/Cosmetics | 08/31/2023 | Voluntary Action Indicated (VAI) |
Saddle Creek Logistics Services | Food/Cosmetics | 07/06/2023 | No Action Indicated (NAI) |
Sovereign Pharmaceuticals, LLC | Drugs | 08/02/2023 | Official Action Indicated (OAI) |
Sterigenics US, LLC | Devices | 08/17/2023 | Voluntary Action Indicated (VAI) |
The Sygma Network | Food/Cosmetics | 01/19/2023 | No Action Indicated (NAI) |