Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
This is a 28.6% increase over the number of companies inspected in the previous quarter, when 21 companies received 21 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 16 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (59.3%). 10 should take voluntary action to correct the organization's management operations (37%). Additionally, one company had to take regulatory and/or administrative actions (3.7%).
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 |
|---|---|---|---|
| 4 Aces Import, Inc. | Food and Cosmetics | 02/10/2023 | No Action Indicated (NAI) |
| Advanced Infusion Solutions | Drugs | 01/30/2023 | Voluntary Action Indicated (VAI) |
| Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Voluntary Action Indicated (VAI) |
| Baylor Institute For Immunology | Biologics | 03/01/2023 | No Action Indicated (NAI) |
| BioLife Plasma Services L. P. | Biologics | 03/23/2023 | No Action Indicated (NAI) |
| DFA Dairy Brands Fluid, LLC | Food and Cosmetics | 01/25/2023 | No Action Indicated (NAI) |
| Dairy Manufacturers, Inc. | Veterinary | 03/27/2023 | No Action Indicated (NAI) |
| Dhaliwal Laboratories, LLC | Veterinary | 02/07/2023 | Voluntary Action Indicated (VAI) |
| El Gordo Spices, LLC | Food and Cosmetics | 03/22/2023 | Voluntary Action Indicated (VAI) |
| Ethen Foods USA, Inc. | Food and Cosmetics | 02/06/2023 | No Action Indicated (NAI) |
| First Fitness International, Inc. | Food and Cosmetics | 01/25/2023 | Voluntary Action Indicated (VAI) |
| Genesis Biosystems, Inc. | Devices | 01/09/2023 | Voluntary Action Indicated (VAI) |
| H2 Beverages, Inc. | Food and Cosmetics | 02/23/2023 | Voluntary Action Indicated (VAI) |
| Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Voluntary Action Indicated (VAI) |
| Mibo Fresh Foods, LLC | Food and Cosmetics | 01/09/2023 | No Action Indicated (NAI) |
| Michael S. Hisey, M.D. | Devices | 01/30/2023 | No Action Indicated (NAI) |
| Orthofix U. S., LLC | Devices | 03/17/2023 | Voluntary Action Indicated (VAI) |
| Performance Food Group, Inc. | Food and Cosmetics | 01/10/2023 | No Action Indicated (NAI) |
| Restaurant Depot | Food and Cosmetics | 01/20/2023 | No Action Indicated (NAI) |
| Somnomed, Inc. | Devices | 03/16/2023 | No Action Indicated (NAI) |
| Southwest Airlines | Food and Cosmetics | 01/25/2023 | No Action Indicated (NAI) |
| Southwest Transplant Alliance, Inc. | Biologics | 02/03/2023 | No Action Indicated (NAI) |
| Taka USA, Inc. | Drugs | 02/07/2023 | Official Action Indicated (OAI) |
| The Sygma Network | Food and Cosmetics | 01/19/2023 | No Action Indicated (NAI) |
| Timothy E. Ritter, M.D. | Drugs | 03/30/2023 | No Action Indicated (NAI) |
| Unifi Aviation, LLC | Food and Cosmetics | 01/25/2023 | Voluntary Action Indicated (VAI) |
| University of Texas Southwestern Medical Center, The | Devices | 02/09/2023 | No Action Indicated (NAI) |
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