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 33.3% increase over the number of companies inspected in the previous quarter, when 12 companies received 12 inspections.
Most of the companies inspected at the time were involved in the Devices and Food and Cosmetics sectors. The second most common type of company inspected worked in the Drugs sector.
There were 11 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (68.8%). Five should take voluntary action to correct their management operations (31.3%).
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 |
|---|---|---|---|
| AmerisourceBergen Drug Corporation | Food and Cosmetics | 06/15/2023 | Voluntary Action Indicated (VAI) |
| Blood Connection, Inc. | Biologics | 06/23/2023 | 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) |
| Deep Blue Medical Advances, Inc. | Devices | 05/18/2023 | No Action Indicated (NAI) |
| Epiphany Craft Malt | Food and Cosmetics | 05/16/2023 | No Action Indicated (NAI) |
| IQVIA Biotech | Drugs | 04/27/2023 | No Action Indicated (NAI) |
| Merz North America, Inc. | Devices | 06/22/2023 | No Action Indicated (NAI) |
| North Carolina State University Dairy Plant | Food and Cosmetics | 06/29/2023 | No Action Indicated (NAI) |
| 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 and Cosmetics | 05/17/2023 | No Action Indicated (NAI) |
| The ICEE Company | Food and Cosmetics | 04/04/2023 | 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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