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 175% increase over the number of companies inspected in the previous year, when four companies were inspected through four 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 Drugs, Devices, and Biologics sectors.
There were 10 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (90.9%). One should take voluntary action to correct the organization's management operations (9.1%).
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 |
---|---|---|---|
CSL Plasma, Inc. | Biologics | 05/19/2023 | No Action Indicated (NAI) |
Charles Fogarty, M.D. | Biologics | 02/15/2023 | No Action Indicated (NAI) |
DFA Dairy Brands Fluid, LLC | Food/Cosmetics | 01/24/2023 | No Action Indicated (NAI) |
Dare Foods, Inc. | Food/Cosmetics | 08/30/2023 | No Action Indicated (NAI) |
Henry F. Butehorn III, M.D. | Drugs | 01/12/2023 | No Action Indicated (NAI) |
Isomedix Operations, Inc. | Devices | 12/13/2023 | No Action Indicated (NAI) |
Palmetto Vermiculite | Food/Cosmetics | 08/10/2023 | No Action Indicated (NAI) |
Refresco Beverages US, Inc. | Food/Cosmetics | 05/24/2023 | No Action Indicated (NAI) |
Rockwell Medical, Inc. | Devices | 12/08/2023 | No Action Indicated (NAI) |
Ultra-Pak, Inc. | Food/Cosmetics | 03/15/2023 | No Action Indicated (NAI) |
Univar Solutions USA, Inc. | Drugs | 12/11/2023 | Voluntary Action Indicated (VAI) |
Univar Solutions USA, Inc. | Food/Cosmetics | 08/03/2023 | No Action Indicated (NAI) |