Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 6.7% decrease from the number of companies inspected in the previous year, when 45 companies were inspected through 46 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 28 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (66.7%). 14 should take voluntary action to correct the organization's management operations (33.3%).
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 |
|---|---|---|---|
| Abraham J. And Phyllis Katz Cord Blood Foundation | Biologics | 09/15/2023 | Voluntary Action Indicated (VAI) |
| All Good Foods, Inc. | Food/Cosmetics | 05/23/2023 | No Action Indicated (NAI) |
| Bay Corporation | Devices | 09/26/2023 | No Action Indicated (NAI) |
| Big Gus Onion Rings, Inc. | Food/Cosmetics | 09/07/2023 | Voluntary Action Indicated (VAI) |
| CIT Ortho | Devices | 09/05/2023 | Voluntary Action Indicated (VAI) |
| CMC Pharmaceuticals, Inc. | Drugs | 09/27/2023 | No Action Indicated (NAI) |
| Cleveland Bean Sprout, Inc. | Food/Cosmetics | 04/10/2023 | Voluntary Action Indicated (VAI) |
| Cleveland Clinic Fertility Center | Biologics | 09/19/2023 | No Action Indicated (NAI) |
| Cleveland Clinic Foundation IRB | Biologics | 06/09/2023 | No Action Indicated (NAI) |
| Cleveland Clinic Foundation IRB | Devices | 06/09/2023 | No Action Indicated (NAI) |
| Cleveland Clinic Foundation IRB | Drugs | 06/09/2023 | No Action Indicated (NAI) |
| Cleveland Clinic South Pointe | Biologics | 10/05/2023 | No Action Indicated (NAI) |
| Cleveland Medical Devices, Inc. | Devices | 07/28/2023 | Voluntary Action Indicated (VAI) |
| Company-AX Technology, Inc. | Devices | 08/02/2023 | Voluntary Action Indicated (VAI) |
| Criterion Tool & Die, Inc. | Devices | 02/17/2023 | Voluntary Action Indicated (VAI) |
| Economy Produce and Vegetable Company, Inc. | Food/Cosmetics | 02/02/2023 | Voluntary Action Indicated (VAI) |
| Farmer Brothers Coffee Company | Food/Cosmetics | 01/03/2023 | No Action Indicated (NAI) |
| Heinen's, Inc. | Food/Cosmetics | 07/26/2023 | No Action Indicated (NAI) |
| Jasmine Distributing, Ltd. | Food/Cosmetics | 01/31/2023 | No Action Indicated (NAI) |
| Lincare, Inc. | Food/Cosmetics | 10/11/2023 | No Action Indicated (NAI) |
| Marc Glassman, Inc. | Food/Cosmetics | 10/25/2023 | No Action Indicated (NAI) |
| Medical Quant USA, Inc. | Devices | 02/06/2023 | No Action Indicated (NAI) |
| MetroHealth Medical Center IRB | Devices | 06/22/2023 | No Action Indicated (NAI) |
| Michael J Rosen, M.D. | Devices | 03/01/2023 | Voluntary Action Indicated (VAI) |
| Nestle Usa, Inc. | Food/Cosmetics | 05/31/2023 | No Action Indicated (NAI) |
| New Dairy Ohio, LLC | Food/Cosmetics | 01/31/2023 | No Action Indicated (NAI) |
| Norman Noble, Inc. | Devices | 03/24/2023 | Voluntary Action Indicated (VAI) |
| Ohio Beverage Systems, Inc. | Food/Cosmetics | 06/12/2023 | No Action Indicated (NAI) |
| Owens and Minor Distribution | Food/Cosmetics | 05/23/2023 | No Action Indicated (NAI) |
| Roe Dental Lab, Inc. | Devices | 10/23/2023 | Voluntary Action Indicated (VAI) |
| Seballos Pastries, LLC | Food/Cosmetics | 02/17/2023 | No Action Indicated (NAI) |
| Signature Flight Support-BKL | Food/Cosmetics | 06/06/2023 | No Action Indicated (NAI) |
| Sky Cafe | Food/Cosmetics | 01/19/2023 | No Action Indicated (NAI) |
| Sonogage, Inc. | Devices | 04/25/2023 | No Action Indicated (NAI) |
| Surgical Theater, Inc. | Devices | 03/03/2023 | Voluntary Action Indicated (VAI) |
| The American National Red Cross | Biologics | 08/18/2023 | No Action Indicated (NAI) |
| The Cleveland Clinic Foundation | Biologics | 09/21/2023 | No Action Indicated (NAI) |
| The Home Pantry, LLC | Food/Cosmetics | 06/15/2023 | No Action Indicated (NAI) |
| The Orlando Baking Company | Food/Cosmetics | 12/08/2023 | Voluntary Action Indicated (VAI) |
| The Tamarkin Company | Food/Cosmetics | 03/15/2023 | No Action Indicated (NAI) |
| University Hospitals Cleveland Medical Center | Biologics | 05/30/2023 | No Action Indicated (NAI) |
| University Hospitals Fertility Center | Biologics | 05/09/2023 | No Action Indicated (NAI) |
| VA Northeast Ohio Healthcare System IRB | Biologics | 07/24/2023 | No Action Indicated (NAI) |
| VA Northeast Ohio Healthcare System IRB | Devices | 07/24/2023 | No Action Indicated (NAI) |
| VA Northeast Ohio Healthcare System IRB | Drugs | 07/24/2023 | No Action Indicated (NAI) |
| Zuga Medical, Inc. | Devices | 06/26/2023 | Voluntary Action Indicated (VAI) |
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