Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
This is a 100% increase over the number of companies inspected in the previous quarter, when five companies received five inspections.
Most of the companies inspected at the time were involved in the Drugs sector. Both the Biologics and Food and Cosmetics sectors sectors tied for second most common type.
There were eight companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (80%). Two should take voluntary action to correct their management operations (20%).
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 |
|---|---|---|---|
| 2C | Food and Cosmetics | 08/01/2023 | No Action Indicated (NAI) |
| AstraZeneca Pharmaceuticals LP | Drugs | 07/18/2023 | No Action Indicated (NAI) |
| BioReliance Corporation | Drugs | 08/04/2023 | No Action Indicated (NAI) |
| Fast-Track Drugs and Biologics, LLC | Drugs | 07/20/2023 | No Action Indicated (NAI) |
| GCDMV, LLC | Food and Cosmetics | 07/24/2023 | Voluntary Action Indicated (VAI) |
| John F. Tisdale, M.D. | Biologics | 09/01/2023 | No Action Indicated (NAI) |
| Macrogenics, Inc. | Drugs | 08/28/2023 | Voluntary Action Indicated (VAI) |
| Michael A. Dempsey, M.D. | Drugs | 08/16/2023 | No Action Indicated (NAI) |
| NIH Donor Center at Fishers Lane | Biologics | 07/26/2023 | No Action Indicated (NAI) |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Drugs | 09/07/2023 | No Action Indicated (NAI) |
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