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 4.2% decrease from the number of companies inspected in the previous year, when 48 companies were inspected through 48 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 sector.
There were 31 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (67.4%). 15 should take voluntary action to correct the organization's management operations (32.6%).
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 |
|---|---|---|---|
| 623 Medical, LLC | Devices | 08/10/2023 | No Action Indicated (NAI) |
| 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) |
| American Red Cross Blood Services | Biologics | 10/16/2023 | Voluntary Action Indicated (VAI) |
| AmerisourceBergen Drug Corporation | Food/Cosmetics | 06/15/2023 | Voluntary Action Indicated (VAI) |
| Aramark Refreshment Services- Raleigh | Food/Cosmetics | 06/15/2023 | No Action Indicated (NAI) |
| Atlantic Fertility Center Partners, LLC | Biologics | 01/11/2023 | No Action Indicated (NAI) |
| Avioq, Inc. | Biologics | 12/05/2023 | Voluntary Action Indicated (VAI) |
| Blood Connection, Inc. | Biologics | 06/23/2023 | No Action Indicated (NAI) |
| CSL Plasma, Inc. | Biologics | 07/21/2023 | No Action Indicated (NAI) |
| Cardinal Health, Inc. | Food/Cosmetics | 09/14/2023 | No Action Indicated (NAI) |
| Carolina Conceptions, PA | Biologics | 06/01/2023 | Voluntary Action Indicated (VAI) |
| CivaTech Oncology, Inc. | Devices | 06/14/2023 | Voluntary Action Indicated (VAI) |
| Clear Choice Therapeutics, Inc. | Devices | 05/11/2023 | Voluntary Action Indicated (VAI) |
| 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) |
| Epiphany Craft Malt | Food/Cosmetics | 05/16/2023 | No Action Indicated (NAI) |
| GlacierPoint Enterprises - Carolinas | Food/Cosmetics | 07/20/2023 | Voluntary Action Indicated (VAI) |
| IQVIA Biotech | Drugs | 04/27/2023 | No Action Indicated (NAI) |
| JMD Marketing, Inc. | Food/Cosmetics | 09/19/2023 | No Action Indicated (NAI) |
| Jad Walters, Ph. D. | Devices | 09/06/2023 | No Action Indicated (NAI) |
| Ladyfingers Catering, LLC | Food/Cosmetics | 08/09/2023 | No Action Indicated (NAI) |
| Lalilab, Inc. | Food/Cosmetics | 03/27/2023 | No Action Indicated (NAI) |
| Luminelle, Inc. | Devices | 02/21/2023 | Voluntary Action Indicated (VAI) |
| Merz North America, Inc. | Devices | 06/22/2023 | No Action Indicated (NAI) |
| North Carolina Center for Reproductive Medicine, Inc. | Biologics | 01/26/2023 | Voluntary Action Indicated (VAI) |
| North Carolina State University Dairy Plant | Food/Cosmetics | 06/29/2023 | No Action Indicated (NAI) |
| North Lily Foods, Inc. | Food/Cosmetics | 10/23/2023 | Voluntary Action Indicated (VAI) |
| Novan, Inc. | Drugs | 06/07/2023 | No Action Indicated (NAI) |
| Premier Research and Consulting | Drugs | 05/17/2023 | No Action Indicated (NAI) |
| R & H Produce, Inc. | Food/Cosmetics | 05/17/2023 | No Action Indicated (NAI) |
| SpringWorks Therapeutics, Inc. | Drugs | 03/31/2023 | Voluntary Action Indicated (VAI) |
| Sweetbottoms Naturals, LLC | Food/Cosmetics | 11/08/2023 | Voluntary Action Indicated (VAI) |
| Syneos Health | Drugs | 02/02/2023 | No Action Indicated (NAI) |
| Syneos Health | Drugs | 07/13/2023 | No Action Indicated (NAI) |
| Syneos Health | Drugs | 08/31/2023 | No Action Indicated (NAI) |
| Syneos Health | Drugs | 12/13/2023 | No Action Indicated (NAI) |
| The ICEE Company | Food/Cosmetics | 04/04/2023 | No Action Indicated (NAI) |
| Thomas L. Ortel, M.D. | Biologics | 07/17/2023 | No Action Indicated (NAI) |
| UCB Biosciences, Inc. | Drugs | 03/24/2023 | No Action Indicated (NAI) |
| UPS Supply Chain Solutions, Inc. | Drugs | 06/29/2023 | No Action Indicated (NAI) |
| Vector Tobacco, LLC | Tobacco | 08/09/2023 | No Action Indicated (NAI) |
| Veloxis Pharmaceuticals, Inc. | Drugs | 05/19/2023 | No Action Indicated (NAI) |
| Wards Fruit & Produce Company | Food/Cosmetics | 01/10/2023 | No Action Indicated (NAI) |
| WatchChild, LLC | Devices | 12/13/2023 | Voluntary Action Indicated (VAI) |
| restor3d, Inc. | Devices | 05/12/2023 | Voluntary Action Indicated (VAI) |
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