Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 6.5% decrease from the number of companies inspected in the previous quarter, when 31 companies received 31 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 Biologics sector.
There were 21 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (72.4%). Eight should take voluntary action to correct their management operations (27.6%).
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.
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 |
|---|---|---|---|
| Advocate Christ Medical Center Transfusion Services | Biologics | 10/25/2024 | No Action Indicated (NAI) |
| Advocate Lutheran General Hospital Transfusion Services | Biologics | 12/05/2024 | Voluntary Action Indicated (VAI) |
| Amtrak Maintenance Facility | Food and Cosmetics | 10/03/2024 | No Action Indicated (NAI) |
| Bajaj Medical, LLC | Drugs | 12/04/2024 | Voluntary Action Indicated (VAI) |
| Coapt, LLC | Devices | 10/28/2024 | Voluntary Action Indicated (VAI) |
| DO&Company Chicago Catering | Food and Cosmetics | 11/29/2024 | Voluntary Action Indicated (VAI) |
| David M. Lubeck, M.D. | Drugs | 11/19/2024 | No Action Indicated (NAI) |
| E-Z Spuds, Inc. | Food and Cosmetics | 12/06/2024 | No Action Indicated (NAI) |
| Gelita USA -Chicago, Inc. | Food and Cosmetics | 11/07/2024 | No Action Indicated (NAI) |
| Grecian Delight/Kronos | Food and Cosmetics | 12/03/2024 | No Action Indicated (NAI) |
| Hammacher Schlemmer | Food and Cosmetics | 11/26/2024 | No Action Indicated (NAI) |
| Interstate Blood Bank of Missouri, Inc. | Biologics | 11/14/2024 | No Action Indicated (NAI) |
| J. Carlos, Inc. | Food and Cosmetics | 12/16/2024 | No Action Indicated (NAI) |
| Jeron Electronic Systems, Inc. | Devices | 12/04/2024 | Voluntary Action Indicated (VAI) |
| Loyola University Medical Center | Biologics | 12/05/2024 | Voluntary Action Indicated (VAI) |
| Lundbeck Pharmaceuticals, LLC | Drugs | 10/25/2024 | No Action Indicated (NAI) |
| Norfolk Medical Products, Inc. | Devices | 12/18/2024 | No Action Indicated (NAI) |
| Rana Meal Solutions, LLC | Food and Cosmetics | 12/23/2024 | No Action Indicated (NAI) |
| Rog Sports Medicine, Inc. | Devices | 11/12/2024 | No Action Indicated (NAI) |
| Sonali S. Chaudhury, M.D. | Biologics | 10/03/2024 | No Action Indicated (NAI) |
| Stepan Company | Food and Cosmetics | 11/20/2024 | No Action Indicated (NAI) |
| Sterigenics International, LLC | Devices | 12/17/2024 | Voluntary Action Indicated (VAI) |
| Taylor Farms Illinois, Inc. | Food and Cosmetics | 11/12/2024 | No Action Indicated (NAI) |
| United Airlines, Inc. | Food and Cosmetics | 10/04/2024 | No Action Indicated (NAI) |
| University of Chicago Medicine - Blood Bank | Biologics | 10/18/2024 | No Action Indicated (NAI) |
| Vee Pak, LLC | Drugs | 12/10/2024 | Voluntary Action Indicated (VAI) |
| Versiti Illinois, Inc. | Biologics | 11/18/2024 | No Action Indicated (NAI) |
| Vitalant | Biologics | 10/29/2024 | No Action Indicated (NAI) |
| Vitalant Reference and Transfusion Service | Biologics | 11/14/2024 | No Action Indicated (NAI) |
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