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 13% increase over the number of companies inspected in the previous year, when 23 companies received 25 inspections.
Most of the companies inspected at the time were involved in the Biologics sector. The second most common type of company inspected period worked in the Devices and Food and Cosmetics sectors.
There were 20 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (76.9%). Six should take voluntary action to correct the organization's management operations (23.1%). Additionally, one company had to take regulatory and/or administrative actions (3.8%).
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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Result |
|---|---|---|---|
| Adventist HealthCare Shady Grove Medical Center | Biologics | 02/22/2024 | No Action Indicated (NAI) |
| Anthrotronix, Inc. | Devices | 08/14/2024 | No Action Indicated (NAI) |
| AstraZeneca Pharmaceuticals LP | Drugs | 05/31/2024 | Voluntary Action Indicated (VAI) |
| AstraZeneca Pharmaceuticals LP | Drugs | 01/22/2024 | No Action Indicated (NAI) |
| AstraZeneca Pharmaceuticals LP | Drugs | 10/25/2024 | No Action Indicated (NAI) |
| Biomat Sciences, Inc. | Devices | 11/19/2024 | No Action Indicated (NAI) |
| Coca-Cola Consolidated, Inc. | Food and Cosmetics | 05/02/2024 | No Action Indicated (NAI) |
| Department of Defense - Navy | Biologics | 10/03/2024 | Voluntary Action Indicated (VAI) |
| Drakes International Corporation | Food and Cosmetics | 09/04/2024 | No Action Indicated (NAI) |
| Fresh Baguette Rockville Center, LLC | Food and Cosmetics | 05/21/2024 | No Action Indicated (NAI) |
| Holy Cross of Silver Spring Blood Bank | Biologics | 10/22/2024 | No Action Indicated (NAI) |
| Kaiser Permanente of the Mid-Atlantic States IRB #7 | Biologics | 02/26/2024 | No Action Indicated (NAI) |
| Kaiser Permanente of the Mid-Atlantic States IRB #7 | Devices | 02/26/2024 | No Action Indicated (NAI) |
| Kaiser Permanente of the Mid-Atlantic States IRB #7 | Drugs | 02/26/2024 | No Action Indicated (NAI) |
| Master Sales, LLC | Tobacco | 11/21/2024 | Voluntary Action Indicated (VAI) |
| Master Sales, LLC | Tobacco | 07/11/2024 | Official Action Indicated (OAI) |
| Montgomery Women's Medical Center, PC | Biologics | 01/17/2024 | No Action Indicated (NAI) |
| Nutricia North America | Food and Cosmetics | 01/30/2024 | No Action Indicated (NAI) |
| Peta-Gay M. Jackson-Booth, M.D. | Biologics | 03/18/2024 | No Action Indicated (NAI) |
| Righteye, LLC | Devices | 03/08/2024 | Voluntary Action Indicated (VAI) |
| SUCO, Inc. | Drugs | 02/25/2024 | Voluntary Action Indicated (VAI) |
| Shady Grove Fertility | Biologics | 04/24/2024 | No Action Indicated (NAI) |
| Shady Grove Reproductive Science Center, PC | Biologics | 04/26/2024 | No Action Indicated (NAI) |
| Susan L. Stramer, PhD | Biologics | 01/24/2024 | No Action Indicated (NAI) |
| Tasly Pharmaceuticals, Inc. | Food and Cosmetics | 04/11/2024 | No Action Indicated (NAI) |
| Tetracore, Inc. | Devices | 12/05/2024 | No Action Indicated (NAI) |
| The American National Red Cross Diagnostic Manufacturing Division | Biologics | 02/13/2024 | No Action Indicated (NAI) |
| U. S. Food and Drug Administration | Devices | 05/08/2024 | No Action Indicated (NAI) |
| United Therapeutics Corporation | Drugs | 05/02/2024 | Voluntary Action Indicated (VAI) |
| Vaccaro's, Inc. | Food and Cosmetics | 02/26/2024 | No Action Indicated (NAI) |
| Women's Fertility and Health Center | Biologics | 07/25/2024 | No Action Indicated (NAI) |
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