Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is a 25.9% increase over the number of companies inspected in the previous year, when 27 companies were inspected through 28 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 29 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (85.3%). Five should take voluntary action to correct the organization's management operations (14.7%).
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 |
|---|---|---|---|
| Alpha Importers, LLC. | Food/Cosmetics | 06/20/2023 | No Action Indicated (NAI) |
| American Australian Medical, Inc. | Devices | 02/23/2023 | No Action Indicated (NAI) |
| Arctic Fisheries, Ltd. | Food/Cosmetics | 04/13/2023 | No Action Indicated (NAI) |
| CSL Plasma, Inc. | Biologics | 07/20/2023 | No Action Indicated (NAI) |
| Chocolate Delivery Systems, Inc. | Food/Cosmetics | 08/22/2023 | No Action Indicated (NAI) |
| DaySpring Distributing | Food/Cosmetics | 05/18/2023 | No Action Indicated (NAI) |
| Elmwood Warehousing Company, Inc. | Food/Cosmetics | 08/14/2023 | No Action Indicated (NAI) |
| Europena Ingredients, Inc. | Food/Cosmetics | 08/02/2023 | No Action Indicated (NAI) |
| Exact Medical Manufacturing, Inc. | Devices | 07/12/2023 | No Action Indicated (NAI) |
| Fresenius Kabi USA, LLC | Drugs | 10/13/2023 | Voluntary Action Indicated (VAI) |
| Fresenius Kabi USA, LLC | Devices | 08/30/2023 | Voluntary Action Indicated (VAI) |
| Fruit Fresh Up, Inc. | Food/Cosmetics | 03/20/2023 | Voluntary Action Indicated (VAI) |
| IMS of Western NY | Food/Cosmetics | 08/17/2023 | No Action Indicated (NAI) |
| Instantwhip Buffalo, Inc. | Food/Cosmetics | 07/20/2023 | No Action Indicated (NAI) |
| J. M. Smucker Company | Veterinary | 12/07/2023 | No Action Indicated (NAI) |
| James Desiderio, Inc. | Food/Cosmetics | 08/28/2023 | No Action Indicated (NAI) |
| Lactalis American Group, Inc. | Food/Cosmetics | 11/07/2023 | No Action Indicated (NAI) |
| Landies Candies, Inc. | Food/Cosmetics | 08/14/2023 | No Action Indicated (NAI) |
| Nyumbani Hakuna Matata, LLC | Food/Cosmetics | 08/24/2023 | Voluntary Action Indicated (VAI) |
| Orthodent Laboratory, Inc. | Devices | 11/13/2023 | Voluntary Action Indicated (VAI) |
| Pellicano Specialty Foods, Inc. | Food/Cosmetics | 12/04/2023 | No Action Indicated (NAI) |
| Perry's Ice Cream Company, Inc. | Food/Cosmetics | 01/12/2023 | No Action Indicated (NAI) |
| Rich Products Corporation | Food/Cosmetics | 09/07/2023 | No Action Indicated (NAI) |
| Rise Baking Company | Food/Cosmetics | 02/02/2023 | No Action Indicated (NAI) |
| Roswell Park Cancer Institute Corporation. Div. Of Pathology | Biologics | 03/13/2023 | No Action Indicated (NAI) |
| Roswell Park Comprehensive Cancer Center IRB | Biologics | 05/19/2023 | No Action Indicated (NAI) |
| Roswell Park Comprehensive Cancer Center IRB | Devices | 05/19/2023 | No Action Indicated (NAI) |
| Roswell Park Comprehensive Cancer Center IRB | Drugs | 05/19/2023 | No Action Indicated (NAI) |
| S J McCullagh, Inc. | Food/Cosmetics | 08/16/2023 | No Action Indicated (NAI) |
| SUNY University of Buffalo IRB | Biologics | 05/12/2023 | No Action Indicated (NAI) |
| SUNY University of Buffalo IRB | Devices | 05/12/2023 | No Action Indicated (NAI) |
| SUNY University of Buffalo IRB | Drugs | 05/12/2023 | No Action Indicated (NAI) |
| Steuben Foods, Inc. | Food/Cosmetics | 10/31/2023 | No Action Indicated (NAI) |
| This and That Canine Company, Inc. | Veterinary | 03/23/2023 | No Action Indicated (NAI) |
| Tripifoods, Inc. | Food/Cosmetics | 08/15/2023 | No Action Indicated (NAI) |
| Tripifoods, Inc. | Veterinary | 10/18/2023 | No Action Indicated (NAI) |
| Upstate Niagara Cooperative, Inc. | Food/Cosmetics | 11/02/2023 | No Action Indicated (NAI) |
| You First Services, Inc. | Devices | 12/18/2023 | Voluntary Action Indicated (VAI) |
| Your Family Fertility, PLLC | Biologics | 02/28/2023 | No Action Indicated (NAI) |
| ZeptoMetrix Corporation | Devices | 02/07/2023 | No Action Indicated (NAI) |
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