Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 14.3% decrease from the number of companies inspected in the previous quarter, when 28 companies received 28 inspections.
Most of the companies inspected at the time were involved in the Food and Cosmetics sector. Both the Biologics and Devices sectors sectors tied for second most common type.
There were 17 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (70.8%). Six should take voluntary action to correct the organization's management operations (25%). Additionally, one company had to take regulatory and/or administrative actions (4.2%).
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 |
|---|---|---|---|
| Advanced Instrumentations, Inc. | Devices | 02/26/2024 | Voluntary Action Indicated (VAI) |
| Bella Vista Bakery | Food and Cosmetics | 03/07/2024 | No Action Indicated (NAI) |
| BioTissue Holdings, Inc. | Devices | 03/06/2024 | Voluntary Action Indicated (VAI) |
| BioTissue Holdings, Inc. | Devices | 03/06/2024 | Voluntary Action Indicated (VAI) |
| CSL Plasma, Inc. | Biologics | 02/16/2024 | No Action Indicated (NAI) |
| Cargo International Consolidators | Food and Cosmetics | 01/02/2024 | No Action Indicated (NAI) |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Official Action Indicated (OAI) |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Voluntary Action Indicated (VAI) |
| Deca & Otto, LLC | Food and Cosmetics | 01/02/2024 | No Action Indicated (NAI) |
| EUSA Global, LLC | Devices | 03/22/2024 | Voluntary Action Indicated (VAI) |
| Eshkol Premium USA, LLC | Food and Cosmetics | 01/12/2024 | No Action Indicated (NAI) |
| Freshway Produce, Inc. | Food and Cosmetics | 02/02/2024 | No Action Indicated (NAI) |
| Gilberto Jimenez, M.D. | Biologics | 01/26/2024 | No Action Indicated (NAI) |
| Innova SoftGel, LLC | Food and Cosmetics | 02/22/2024 | No Action Indicated (NAI) |
| Medipharm Laboratories, Inc. | Drugs | 02/23/2024 | Voluntary Action Indicated (VAI) |
| Miami VA Healthcare System | Biologics | 01/26/2024 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 02/13/2024 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 03/20/2024 | No Action Indicated (NAI) |
| Orbis Medical, Inc. | Devices | 01/23/2024 | No Action Indicated (NAI) |
| Plus One Usa, LLC | Food and Cosmetics | 03/21/2024 | No Action Indicated (NAI) |
| Rishi Kakar, M.D. | Drugs | 01/22/2024 | No Action Indicated (NAI) |
| Southern Edge Orthpaedics | Biologics | 01/16/2024 | No Action Indicated (NAI) |
| Spice Distributor, Inc. | Food and Cosmetics | 03/19/2024 | No Action Indicated (NAI) |
| These Three Medical, LLC | Devices | 01/08/2024 | No Action Indicated (NAI) |
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