Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 37.5% increase over the number of companies inspected in the previous year, when 32 companies were inspected through 32 inspections.
Most of the companies inspected were involved in the Food/Cosmetics sector. The second most common type of company inspected in the time period worked in the Devices sector.
There were 30 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (68.2%). 13 should take voluntary action to correct the organization's management operations (29.5%). Additionally, one company had to take regulatory and/or administrative actions (2.3%).
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 |
|---|---|---|---|
| A Childs Hope International | Food/Cosmetics | 01/18/2023 | No Action Indicated (NAI) |
| Advanced Testing Laboratory, Inc. | Drugs | 11/09/2023 | Voluntary Action Indicated (VAI) |
| AlloSource, Inc. | Biologics | 09/07/2023 | No Action Indicated (NAI) |
| Aram Zabeti, M.D. | Drugs | 03/22/2023 | No Action Indicated (NAI) |
| Baxters North America, Inc. | Food/Cosmetics | 07/26/2023 | Voluntary Action Indicated (VAI) |
| Bethesda Fertility Center | Biologics | 03/22/2023 | Voluntary Action Indicated (VAI) |
| Biomat USA, Inc. | Biologics | 10/13/2023 | No Action Indicated (NAI) |
| Bryan Medical, Inc. | Devices | 02/01/2023 | No Action Indicated (NAI) |
| Cincinnati Childrens Hospital Medical Center | Biologics | 07/12/2023 | Voluntary Action Indicated (VAI) |
| Control Bionics | Devices | 06/06/2023 | No Action Indicated (NAI) |
| David W. Mayleben PhD | Drugs | 10/26/2023 | No Action Indicated (NAI) |
| Dynavision Global Holdings, LLC | Devices | 08/31/2023 | Voluntary Action Indicated (VAI) |
| Enable Injections, Inc. | Devices | 05/05/2023 | No Action Indicated (NAI) |
| Enable Injections, Inc. | Devices | 05/05/2023 | No Action Indicated (NAI) |
| Enson Group, Inc. | Food/Cosmetics | 04/24/2023 | Voluntary Action Indicated (VAI) |
| Enson Group, Inc. | Food/Cosmetics | 04/26/2023 | No Action Indicated (NAI) |
| Ethicon Endo-Surgery, Inc. | Devices | 08/04/2023 | No Action Indicated (NAI) |
| FKC, LLC | Food/Cosmetics | 04/07/2023 | Voluntary Action Indicated (VAI) |
| Feedworks USA, Ltd. | Veterinary | 04/28/2023 | No Action Indicated (NAI) |
| Garys Cheesecakes & Fine Desserts | Food/Cosmetics | 02/15/2023 | Official Action Indicated (OAI) |
| Garys Cheesecakes & Fine Desserts | Food/Cosmetics | 10/20/2023 | No Action Indicated (NAI) |
| Givaudan Flavors, Corp. | Food/Cosmetics | 07/21/2023 | No Action Indicated (NAI) |
| Graeter's Ice Cream Company | Food/Cosmetics | 03/02/2023 | 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/Cosmetics | 07/21/2023 | Voluntary Action Indicated (VAI) |
| La Antigua Bakery & Grocery, LLC | Food/Cosmetics | 04/19/2023 | No Action Indicated (NAI) |
| LifeCenter Organ Donor Network | Biologics | 06/06/2023 | No Action Indicated (NAI) |
| Love Force, LLC | Food/Cosmetics | 06/09/2023 | Voluntary Action Indicated (VAI) |
| Medpace, Inc. | Drugs | 03/23/2023 | No Action Indicated (NAI) |
| Megadyne Medical Products, Inc. | Devices | 06/06/2023 | No Action Indicated (NAI) |
| Midwest Tobacco Tube, Inc. | Tobacco | 03/21/2023 | No Action Indicated (NAI) |
| Ohio Fertility Providers, LLC | Biologics | 08/30/2023 | No Action Indicated (NAI) |
| Parrillo Performance, Inc. | Food/Cosmetics | 07/10/2023 | No Action Indicated (NAI) |
| Patheon Pharmaceuticals, Inc. | Drugs | 04/21/2023 | No Action Indicated (NAI) |
| Performance Foodservice, Inc. | Food/Cosmetics | 09/12/2023 | No Action Indicated (NAI) |
| Richard B. Powell, M.D. | Biologics | 05/24/2023 | Voluntary Action Indicated (VAI) |
| Signature Flight Support -LUK | Food/Cosmetics | 05/11/2023 | No Action Indicated (NAI) |
| Stacey Ishman, M.D. | Devices | 01/17/2023 | No Action Indicated (NAI) |
| Standard Textile Company, Inc. | Devices | 07/12/2023 | No Action Indicated (NAI) |
| Steven G. Rudick, M.D. | Devices | 12/08/2023 | No Action Indicated (NAI) |
| Surgical Appliance Industries, Inc. | Devices | 10/18/2023 | Voluntary Action Indicated (VAI) |
| Teva Womens Health, LLC | Drugs | 04/07/2023 | No Action Indicated (NAI) |
| The Pickled Pig | Food/Cosmetics | 03/30/2023 | No Action Indicated (NAI) |
| The Pickled Pig | Veterinary | 03/30/2023 | No Action Indicated (NAI) |
| Torax Medical, Inc. | Devices | 11/16/2023 | 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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