Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 36.1% decrease from the number of companies inspected in the previous year, when 72 companies were inspected through 75 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 20 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (43.5%). 26 should take voluntary action to correct the organization's management operations (56.5%).
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. M. Surgical, Inc. | Devices | 10/20/2023 | Voluntary Action Indicated (VAI) |
| AMP Nutraceuticals | Food/Cosmetics | 11/21/2023 | Voluntary Action Indicated (VAI) |
| Abel & Schafer, Inc. | Food/Cosmetics | 01/25/2023 | Voluntary Action Indicated (VAI) |
| Accuon Labs, Inc. | Drugs | 08/31/2023 | No Action Indicated (NAI) |
| Ackermann Usa, Inc. | Devices | 08/04/2023 | Voluntary Action Indicated (VAI) |
| All Star Specialties Corporation | Food/Cosmetics | 02/22/2023 | Voluntary Action Indicated (VAI) |
| Always Bagels NY, LLC | Food/Cosmetics | 12/11/2023 | No Action Indicated (NAI) |
| Amneal Pharmaceuticals of New York, LLC | Drugs | 06/07/2023 | No Action Indicated (NAI) |
| Banyan International, LLC | Food/Cosmetics | 11/15/2023 | No Action Indicated (NAI) |
| Banyan USA, LLC | Devices | 09/12/2023 | Voluntary Action Indicated (VAI) |
| Bay Shore Medical Equipment, LLC | Devices | 05/02/2023 | No Action Indicated (NAI) |
| Belstel Foods, Inc. | Food/Cosmetics | 08/02/2023 | No Action Indicated (NAI) |
| Bob Gosman Company, Inc. | Food/Cosmetics | 10/19/2023 | Voluntary Action Indicated (VAI) |
| Broadway Heights Dairy, Inc. | Food/Cosmetics | 04/20/2023 | Voluntary Action Indicated (VAI) |
| Calico Cottage, Inc. | Food/Cosmetics | 09/07/2023 | No Action Indicated (NAI) |
| Casella Specialties, Inc. | Food/Cosmetics | 07/11/2023 | No Action Indicated (NAI) |
| Casella Specialties, Inc. | Food/Cosmetics | 09/20/2023 | No Action Indicated (NAI) |
| Comax Manufacturing Corporation | Food/Cosmetics | 04/20/2023 | No Action Indicated (NAI) |
| Cookies United, LLC. | Food/Cosmetics | 12/04/2023 | No Action Indicated (NAI) |
| Due Amici Imports, Inc. | Food/Cosmetics | 03/23/2023 | Voluntary Action Indicated (VAI) |
| Fougera Pharmaceuticals, Inc. | Drugs | 12/08/2023 | No Action Indicated (NAI) |
| Fougera Pharmaceuticals, Inc. | Veterinary | 12/08/2023 | No Action Indicated (NAI) |
| G Fuel, LLC | Food/Cosmetics | 07/05/2023 | Voluntary Action Indicated (VAI) |
| In Store Distributors, Inc. | Food/Cosmetics | 03/21/2023 | Voluntary Action Indicated (VAI) |
| InvaGen Pharmaceuticals, Inc. | Drugs | 09/19/2023 | Voluntary Action Indicated (VAI) |
| InvaGen Pharmaceuticals, Inc. | Veterinary | 09/19/2023 | Voluntary Action Indicated (VAI) |
| InvaGen Pharmaceuticals, Inc. | Drugs | 10/25/2023 | No Action Indicated (NAI) |
| Kie Industries, LLC | Tobacco | 08/16/2023 | Voluntary Action Indicated (VAI) |
| La Ricura Foods, Ltd. | Food/Cosmetics | 08/21/2023 | Voluntary Action Indicated (VAI) |
| LifeVac, LLC | Devices | 05/25/2023 | No Action Indicated (NAI) |
| Madcar A Division of Century Direct Solutions | Drugs | 12/20/2023 | Voluntary Action Indicated (VAI) |
| Madcar A Division of Century Direct Solutions | Food/Cosmetics | 10/05/2023 | No Action Indicated (NAI) |
| Mark D. Epstein, M.D. | Devices | 06/28/2023 | No Action Indicated (NAI) |
| Mauro Pennisi, Inc. | Food/Cosmetics | 08/08/2023 | No Action Indicated (NAI) |
| Mirion Technologies | Devices | 02/10/2023 | Voluntary Action Indicated (VAI) |
| Modern Italian Bakery of West Babylon, Inc. | Food/Cosmetics | 11/14/2023 | No Action Indicated (NAI) |
| Muscle Sport Products, LLC | Food/Cosmetics | 05/09/2023 | Voluntary Action Indicated (VAI) |
| Nature's Value, Inc. | Food/Cosmetics | 02/08/2023 | Voluntary Action Indicated (VAI) |
| New York Blood Center Enterprises | Biologics | 12/22/2023 | Voluntary Action Indicated (VAI) |
| Phoenix Wipes, Inc. | Drugs | 12/19/2023 | Voluntary Action Indicated (VAI) |
| Piping Rock Health Products | Food/Cosmetics | 05/18/2023 | No Action Indicated (NAI) |
| RV Pharma, LLC | Food/Cosmetics | 07/19/2023 | No Action Indicated (NAI) |
| Red Medical Solutions, Inc. | Devices | 03/22/2023 | Voluntary Action Indicated (VAI) |
| Saptalis Pharmaceuticals, LLC | Drugs | 03/17/2023 | Voluntary Action Indicated (VAI) |
| Sleep Joy International, LLC | Devices | 01/20/2023 | Voluntary Action Indicated (VAI) |
| Source-Ray, Inc. | Devices | 02/07/2023 | No Action Indicated (NAI) |
| Spirit Pharmaceuticals | Drugs | 11/01/2023 | Voluntary Action Indicated (VAI) |
| Stony Brook University Medical Center | Biologics | 02/07/2023 | Voluntary Action Indicated (VAI) |
| W. A. Baum Company, Inc. | Devices | 11/06/2023 | Voluntary Action Indicated (VAI) |
| Whitsons Food Service, LLC. | Food/Cosmetics | 10/23/2023 | No Action Indicated (NAI) |
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