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 an 18.2% increase over the number of companies inspected in the previous quarter, when 11 companies received 11 inspections.
Most of the companies inspected at the time were involved in the Drugs sector. The Biologics and Food and Cosmetics sectors sectors, along with one other sector, tied for second most common type.
There were nine companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (69.2%). Four should take voluntary action to correct their management operations (30.8%).
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 |
|---|---|---|---|
| Ablexan Corporation | Devices | 01/23/2023 | No Action Indicated (NAI) |
| Alcami Carolinas Corporation | Drugs | 03/13/2023 | Voluntary Action Indicated (VAI) |
| Allison K. Ross, M.D. | Drugs | 02/16/2023 | No Action Indicated (NAI) |
| Atlantic Fertility Center Partners, LLC | Biologics | 01/11/2023 | 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) |
| Lalilab, Inc. | Food and Cosmetics | 03/27/2023 | No Action Indicated (NAI) |
| Luminelle, Inc. | Devices | 02/21/2023 | Voluntary Action Indicated (VAI) |
| North Carolina Center for Reproductive Medicine, Inc. | Biologics | 01/26/2023 | Voluntary Action Indicated (VAI) |
| SpringWorks Therapeutics, Inc. | Drugs | 03/31/2023 | Voluntary Action Indicated (VAI) |
| Syneos Health | Drugs | 02/02/2023 | No Action Indicated (NAI) |
| UCB Biosciences, Inc. | Drugs | 03/24/2023 | No Action Indicated (NAI) |
| Wards Fruit & Produce Company | Food and Cosmetics | 01/10/2023 | No Action Indicated (NAI) |
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