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 600% increase over the number of companies inspected in the previous quarter, when one company received one inspection.
Most of the companies inspected at the time were involved in the Biologics and Drugs sectors. The second most common type of company inspected worked in the Veterinary sector.
There were six companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. One should take voluntary action to correct its management operations.
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 |
|---|---|---|---|
| Augusto Miravalle, M.D. | Drugs | 01/25/2023 | No Action Indicated (NAI) |
| BarkDine Innovations, LLC | Veterinary | 03/22/2023 | No Action Indicated (NAI) |
| CSL Plasma, Inc. | Biologics | 01/05/2023 | No Action Indicated (NAI) |
| CryoGam Colorado, LLC. | Biologics | 01/10/2023 | No Action Indicated (NAI) |
| Medical Center Of The Rockies | Biologics | 01/13/2023 | No Action Indicated (NAI) |
| TOLMAR, Inc. | Drugs | 01/31/2023 | No Action Indicated (NAI) |
| Tolmar, Inc. | Drugs | 01/31/2023 | Voluntary Action Indicated (VAI) |
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