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 21.4% decrease from the number of companies inspected in the previous year, when 14 companies were inspected through 14 inspections.
Most of the companies inspected were involved in the Biologics and Food/Cosmetics sectors. The second most common type of company inspected in the time period worked in the Devices, Drugs, and Veterinary sectors.
There were nine companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (81.8%). Two should take voluntary action to correct the organization's management operations (18.2%).
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 |
---|---|---|---|
A-Ox Welding Supply Company, Inc. | Drugs | 07/17/2023 | Voluntary Action Indicated (VAI) |
Avera McKennan Hospital & University Health Center | Biologics | 10/25/2023 | No Action Indicated (NAI) |
Gentle Giants | Veterinary | 06/01/2023 | No Action Indicated (NAI) |
Glanbia Nutritionals | Food/Cosmetics | 05/23/2023 | No Action Indicated (NAI) |
Midwest Eye Laboratories Sioux Falls, LLC | Devices | 07/27/2023 | No Action Indicated (NAI) |
Nordica Warehouses, Inc. | Food/Cosmetics | 03/21/2023 | No Action Indicated (NAI) |
Pan-O-Gold Baking Company | Food/Cosmetics | 03/21/2023 | No Action Indicated (NAI) |
Roodle, L.L.C. | Food/Cosmetics | 09/27/2023 | Voluntary Action Indicated (VAI) |
Sanford Medical Center | Biologics | 10/27/2023 | No Action Indicated (NAI) |
Sanford Women's Health Advanced Reproductive Laboratory | Biologics | 05/11/2023 | No Action Indicated (NAI) |
South Dakota Lions Eye Bank, Inc. | Biologics | 10/31/2023 | No Action Indicated (NAI) |