DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is a 140% 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 Food and Cosmetics sector. The second most common type of company inspected worked in the Devices sector.
There were five companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (41.7%). Six should take voluntary action to correct the organization's management operations (50%). Additionally, one company had to take regulatory and/or administrative actions (8.3%).
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 |
|---|---|---|---|
| Affiliated Imports, LLC | Tobacco | 08/03/2023 | No Action Indicated (NAI) |
| American Airlines | Food and Cosmetics | 09/14/2023 | Voluntary Action Indicated (VAI) |
| Atlantic Aviation, LLC | Food and Cosmetics | 09/13/2023 | No Action Indicated (NAI) |
| CieloWorks, Inc. | Biologics | 08/18/2023 | Voluntary Action Indicated (VAI) |
| Ensemble Orthopedics, Inc. | Devices | 08/04/2023 | Voluntary Action Indicated (VAI) |
| Genesys Orthopedics Systems, LLC | Devices | 08/10/2023 | No Action Indicated (NAI) |
| Isik Organic Company | Food and Cosmetics | 09/20/2023 | No Action Indicated (NAI) |
| Lsg Sky Chefs, Inc. | Food and Cosmetics | 09/18/2023 | Voluntary Action Indicated (VAI) |
| Pastel Cartel, LLC | Tobacco | 08/03/2023 | Voluntary Action Indicated (VAI) |
| Shantaba, LLC | Food and Cosmetics | 07/07/2023 | Official Action Indicated (OAI) |
| SpineSmith Holdings, LLC | Devices | 08/01/2023 | Voluntary Action Indicated (VAI) |
| Virtex | Devices | 08/02/2023 | No Action Indicated (NAI) |
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