Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 15.4% increase over the number of companies inspected in the previous quarter, when 13 companies received 15 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 nine companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (60%). Six should take voluntary action to correct their management operations (40%).
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 |
|---|---|---|---|
| AlloSource, Inc. | Biologics | 09/07/2023 | No Action Indicated (NAI) |
| Baxters North America, Inc. | Food and Cosmetics | 07/26/2023 | Voluntary Action Indicated (VAI) |
| Cincinnati Childrens Hospital Medical Center | Biologics | 07/12/2023 | Voluntary Action Indicated (VAI) |
| Dynavision Global Holdings, LLC | Devices | 08/31/2023 | Voluntary Action Indicated (VAI) |
| Ethicon Endo-Surgery, Inc. | Devices | 08/04/2023 | No Action Indicated (NAI) |
| Givaudan Flavors, Corp. | Food and Cosmetics | 07/21/2023 | No Action Indicated (NAI) |
| Hoxworth Blood Center University of Cincinnati | Biologics | 09/28/2023 | No Action Indicated (NAI) |
| Interplex Medical, LLC | Devices | 09/20/2023 | No Action Indicated (NAI) |
| Kaiser Foods, Inc. | Food and Cosmetics | 07/21/2023 | Voluntary Action Indicated (VAI) |
| Ohio Fertility Providers, LLC | Biologics | 08/30/2023 | No Action Indicated (NAI) |
| Parrillo Performance, Inc. | Food and Cosmetics | 07/10/2023 | No Action Indicated (NAI) |
| Performance Foodservice, Inc. | Food and Cosmetics | 09/12/2023 | No Action Indicated (NAI) |
| Standard Textile Company, Inc. | Devices | 07/12/2023 | No Action Indicated (NAI) |
| Univar Solutions USA, Inc. | Veterinary | 08/11/2023 | Voluntary Action Indicated (VAI) |
| Wilbur-Ellis Nutrition | Veterinary | 08/16/2023 | Voluntary Action Indicated (VAI) |
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