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 25% increase over the number of companies inspected in the previous year, when 20 companies were inspected through 20 inspections.
Most of the companies inspected were involved in the Drugs sector. The second most common type of company inspected in the time period worked in the Food/Cosmetics sector.
There were 19 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (76%). Six should take voluntary action to correct the organization's management operations (24%).
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 |
|---|---|---|---|
| Alcami Carolinas Corporation | Drugs | 03/13/2023 | Voluntary Action Indicated (VAI) |
| Allison K. Ross, M.D. | Drugs | 02/16/2023 | No Action Indicated (NAI) |
| American Red Cross Blood Services | Biologics | 10/16/2023 | Voluntary Action Indicated (VAI) |
| Avioq, Inc. | Biologics | 12/05/2023 | Voluntary Action Indicated (VAI) |
| Becton Dickinson and Company | Devices | 09/15/2023 | No Action Indicated (NAI) |
| Big Spoon Roasters, LLC | Food/Cosmetics | 10/18/2023 | No Action Indicated (NAI) |
| Bleep, LLC | Devices | 08/25/2023 | Voluntary Action Indicated (VAI) |
| Cardinal Health, Inc. | Food/Cosmetics | 09/14/2023 | No Action Indicated (NAI) |
| Chapel Hill Creamery, LLC | Food/Cosmetics | 11/27/2023 | No Action Indicated (NAI) |
| Cristina Gasparetto, M.D. | Drugs | 09/29/2023 | No Action Indicated (NAI) |
| Deep Blue Medical Advances, Inc. | Devices | 05/18/2023 | No Action Indicated (NAI) |
| Durham Exchange Club Industries, Inc. | Tobacco | 02/21/2023 | No Action Indicated (NAI) |
| Edward C. Smith, M.D. | Drugs | 03/17/2023 | No Action Indicated (NAI) |
| Edwin H. Kim, M.D. | Drugs | 11/08/2023 | No Action Indicated (NAI) |
| Epiphany Craft Malt | Food/Cosmetics | 05/16/2023 | No Action Indicated (NAI) |
| IQVIA Biotech | Drugs | 04/27/2023 | No Action Indicated (NAI) |
| Jad Walters, Ph. D. | Devices | 09/06/2023 | No Action Indicated (NAI) |
| Lalilab, Inc. | Food/Cosmetics | 03/27/2023 | No Action Indicated (NAI) |
| Liggett Group, LLC | Tobacco | 09/07/2023 | No Action Indicated (NAI) |
| Maple View Ice Cream | Food/Cosmetics | 08/17/2023 | No Action Indicated (NAI) |
| Novan, Inc. | Drugs | 06/07/2023 | No Action Indicated (NAI) |
| SpringWorks Therapeutics, Inc. | Drugs | 03/31/2023 | Voluntary Action Indicated (VAI) |
| Thomas L. Ortel, M.D. | Biologics | 07/17/2023 | No Action Indicated (NAI) |
| UPS Supply Chain Solutions, Inc. | Drugs | 06/29/2023 | No Action Indicated (NAI) |
| restor3d, Inc. | Devices | 05/12/2023 | Voluntary Action Indicated (VAI) |
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