Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 17.6% decrease from the number of companies inspected in the previous year, when 17 companies were inspected through 17 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 11 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (78.6%). Three should take voluntary action to correct the organization's management operations (21.4%).
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) |
| 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) |
| Conceptions Reproductive Associates Diagnostic Lab | Biologics | 08/08/2023 | 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) |
| 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) |
| Reece, Thomas Brett, M.D. | Devices | 12/13/2023 | No Action Indicated (NAI) |
| University of Colorado-Saint Louis Cord Blood Bank | Biologics | 09/15/2023 | No Action Indicated (NAI) |
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