Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 31.3% decrease from the number of companies inspected in the previous quarter, when 16 companies received 16 inspections.
Most of the companies inspected at the time were involved in the Food and Cosmetics and Devices sectors. Both the Biologics and Drugs sectors sectors 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 (81.8%). Two should take voluntary action to correct their management operations (18.2%).
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) |
| Bleep, LLC | Devices | 08/25/2023 | Voluntary Action Indicated (VAI) |
| CSL Plasma, Inc. | Biologics | 07/21/2023 | No Action Indicated (NAI) |
| Cardinal Health, Inc. | Food and Cosmetics | 09/14/2023 | No Action Indicated (NAI) |
| Cristina Gasparetto, M.D. | Drugs | 09/29/2023 | No Action Indicated (NAI) |
| GlacierPoint Enterprises - Carolinas | Food and Cosmetics | 07/20/2023 | Voluntary Action Indicated (VAI) |
| Jad Walters, Ph. D. | Devices | 09/06/2023 | No Action Indicated (NAI) |
| Ladyfingers Catering, LLC | Food and Cosmetics | 08/09/2023 | No Action Indicated (NAI) |
| Syneos Health | Drugs | 07/13/2023 | No Action Indicated (NAI) |
| Syneos Health | Drugs | 08/31/2023 | No Action Indicated (NAI) |
| Thomas L. Ortel, M.D. | Biologics | 07/17/2023 | No Action Indicated (NAI) |
| Vector Tobacco, LLC | Tobacco | 08/09/2023 | No Action Indicated (NAI) |
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