Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is a 100% increase over the number of companies inspected in the previous year, when six companies were inspected through six 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 Food/Cosmetics sector.
There were nine companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (75%). Three should take voluntary action to correct the organization's management operations (25%).
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 |
|---|---|---|---|
| CSL Plasma | Biologics | 08/11/2023 | No Action Indicated (NAI) |
| Children's Hospital of the King's Daughters | Biologics | 10/16/2023 | No Action Indicated (NAI) |
| Cristina Baldassari, M.D. | Devices | 02/23/2023 | No Action Indicated (NAI) |
| Fortis Surgical, LLC | Biologics | 12/12/2023 | No Action Indicated (NAI) |
| Lions Medical Eye Bank & Research Center of Eastern VA | Biologics | 02/16/2023 | Voluntary Action Indicated (VAI) |
| Nauticus, City of Norfolk | Food/Cosmetics | 08/23/2023 | No Action Indicated (NAI) |
| S. C. Medical Overseas, Inc. | Devices | 07/11/2023 | No Action Indicated (NAI) |
| The American National Red Cross | Biologics | 07/10/2023 | Voluntary Action Indicated (VAI) |
| The Gourmet Gang, Inc. | Food/Cosmetics | 04/05/2023 | No Action Indicated (NAI) |
| Tidewater Foods | Food/Cosmetics | 01/18/2023 | No Action Indicated (NAI) |
| Virginia International Terminal, LLC | Food/Cosmetics | 02/16/2023 | No Action Indicated (NAI) |
| Zimmer Biomet | Devices | 08/18/2023 | Voluntary Action Indicated (VAI) |
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