Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is a 36.4% decrease from the number of companies inspected in the previous year, when 33 companies were inspected through 33 inspections.
Most of the companies inspected were involved in the Drugs sector. The second most common type of company inspected in the time period worked in the Food/Cosmetics sector.
There were 15 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (71.4%). Six should take voluntary action to correct the organization's management operations (28.6%).
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/Cosmetics | 08/01/2023 | No Action Indicated (NAI) |
| Altos del Tio Conejo, LLC | Food/Cosmetics | 03/16/2023 | 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) |
| Cima Food, Inc. | Food/Cosmetics | 05/26/2023 | Voluntary Action Indicated (VAI) |
| Elia E. Acevedo Diaz | Drugs | 12/12/2023 | No Action Indicated (NAI) |
| Fast-Track Drugs and Biologics, LLC | Drugs | 07/20/2023 | No Action Indicated (NAI) |
| GCDMV, LLC | Food/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) |
| Maxim Biomedical, Inc. | Devices | 11/02/2023 | No Action Indicated (NAI) |
| Michael A. Dempsey, M.D. | Drugs | 08/16/2023 | No Action Indicated (NAI) |
| Michael J. Lenardo, M.D. | Drugs | 03/23/2023 | No Action Indicated (NAI) |
| Mr. Omelette Papa's Foods | Food/Cosmetics | 04/21/2023 | No Action Indicated (NAI) |
| NIH Donor Center at Fishers Lane | Biologics | 07/26/2023 | No Action Indicated (NAI) |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Drugs | 02/27/2023 | No Action Indicated (NAI) |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Drugs | 09/07/2023 | No Action Indicated (NAI) |
| Reveragen Biopharma, Inc. | Drugs | 03/06/2023 | Voluntary Action Indicated (VAI) |
| Sabouya International Foods, LLC | Food/Cosmetics | 10/31/2023 | Voluntary Action Indicated (VAI) |
| Sacred Mountain, LLC | Food/Cosmetics | 04/11/2023 | No Action Indicated (NAI) |
| Walter Reed Army Institute of Research IRB | Biologics | 06/16/2023 | No Action Indicated (NAI) |
| Walter Reed Army Institute of Research IRB | Devices | 06/16/2023 | No Action Indicated (NAI) |
| Walter Reed Army Institute of Research IRB | Drugs | 06/16/2023 | No Action Indicated (NAI) |
| Wayne Farnsworth, M.D. | Biologics | 06/27/2023 | Voluntary Action Indicated (VAI) |
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