Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is a 14.8% decrease from the number of companies inspected in the previous year, when 27 companies were inspected through 27 inspections.
Most of the companies inspected were involved in the Biologics sector. The second most common type of company inspected in the time period worked in the Devices sector.
There were 16 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (69.6%). Seven should take voluntary action to correct the organization's management operations (30.4%).
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 |
|---|---|---|---|
| Acme Delivery Service, Incorporated | Veterinary | 12/21/2023 | No Action Indicated (NAI) |
| Allison Medical, Inc. | Devices | 04/28/2023 | Voluntary Action Indicated (VAI) |
| AlloSource | Biologics | 03/30/2023 | Voluntary Action Indicated (VAI) |
| CSL Plasma, Inc. | Biologics | 04/07/2023 | No Action Indicated (NAI) |
| ClinImmune Labs-University Colorado Cord Blood Bank and Stem Cell Lab | Biologics | 09/19/2023 | No Action Indicated (NAI) |
| CoRE labs, LLC | Devices | 06/21/2023 | Voluntary Action Indicated (VAI) |
| Colorado Nut Holding Company | Food/Cosmetics | 12/06/2023 | No Action Indicated (NAI) |
| D. O. Weaver and Company | Devices | 05/12/2023 | Voluntary Action Indicated (VAI) |
| David Fleischer, M.D. | Drugs | 01/27/2023 | No Action Indicated (NAI) |
| Dry Bones Denver | Food/Cosmetics | 02/13/2023 | No Action Indicated (NAI) |
| Elaine T. Lam, M.D. | Drugs | 11/03/2023 | No Action Indicated (NAI) |
| King Soopers Reclamation Center | Food/Cosmetics | 04/18/2023 | No Action Indicated (NAI) |
| King Soopers Reclamation Center | Veterinary | 04/18/2023 | No Action Indicated (NAI) |
| Lewis, Karl D., M.D. | Biologics | 08/07/2023 | Voluntary Action Indicated (VAI) |
| Lucina BioSciences, LLC | Biologics | 12/18/2023 | No Action Indicated (NAI) |
| Medical Modeling, a 3D Systems Company | Devices | 09/15/2023 | No Action Indicated (NAI) |
| Melamed, Isaac R., M.D. | Biologics | 09/01/2023 | No Action Indicated (NAI) |
| Paragon 28, Inc. | Devices | 07/13/2023 | No Action Indicated (NAI) |
| Provital, Inc. | Veterinary | 10/04/2023 | No Action Indicated (NAI) |
| Reece, Thomas Brett, M.D. | Devices | 12/13/2023 | No Action Indicated (NAI) |
| Share Good Foods, Inc. | Food/Cosmetics | 02/23/2023 | Voluntary Action Indicated (VAI) |
| University of Colorado-Saint Louis Cord Blood Bank | Biologics | 09/15/2023 | No Action Indicated (NAI) |
| Wright Medical Technology, Inc. | Biologics | 08/09/2023 | No Action Indicated (NAI) |
| Yoshicon, LLC | Tobacco | 08/10/2023 | Voluntary Action Indicated (VAI) |
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