Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 22.4% decrease from the number of companies inspected in the previous year, when 76 companies were inspected through 79 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 (47.5%). 29 should take voluntary action to correct the organization's management operations (49.2%). Additionally, four companies had to take regulatory and/or administrative actions (6.8%).
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 |
|---|---|---|---|
| 3-D Matrix, Inc. | Devices | 10/18/2023 | Voluntary Action Indicated (VAI) |
| Alcresta Therapeutics, Inc. | Devices | 08/16/2023 | No Action Indicated (NAI) |
| Anika Therapeutics, Inc. | Veterinary | 08/09/2023 | Voluntary Action Indicated (VAI) |
| Apellis Pharmaceuticals, Inc. | Drugs | 07/14/2023 | No Action Indicated (NAI) |
| AxioMed, LLC. | Devices | 01/13/2023 | Voluntary Action Indicated (VAI) |
| Azurity Pharmaceuticals, Inc. | Drugs | 03/02/2023 | No Action Indicated (NAI) |
| Barkey Corporation | Devices | 07/31/2023 | Voluntary Action Indicated (VAI) |
| Barrett Technology, LLC | Devices | 03/07/2023 | Voluntary Action Indicated (VAI) |
| Bedford Research Foundation, Inc. | Biologics | 08/15/2023 | No Action Indicated (NAI) |
| Beekman Foods, Inc. | Food/Cosmetics | 04/24/2023 | Voluntary Action Indicated (VAI) |
| Biosensics, LLC | Devices | 04/07/2023 | Voluntary Action Indicated (VAI) |
| Brammer Bio MA, LLC | Biologics | 08/30/2023 | Voluntary Action Indicated (VAI) |
| Brammer Bio MA, LLC | Biologics | 12/19/2023 | Voluntary Action Indicated (VAI) |
| Brigham and Women's Hospital | Biologics | 08/16/2023 | No Action Indicated (NAI) |
| CCRM Boston, PLLC | Biologics | 07/20/2023 | No Action Indicated (NAI) |
| Candela Corporation | Devices | 01/24/2023 | Voluntary Action Indicated (VAI) |
| Care Everywhere, LLC | Devices | 08/16/2023 | No Action Indicated (NAI) |
| Checkpoint Therapeutics, Inc. | Drugs | 06/16/2023 | No Action Indicated (NAI) |
| Conformis, Inc. | Devices | 03/09/2023 | Voluntary Action Indicated (VAI) |
| Curia Massachusetts, Inc. | Drugs | 06/29/2023 | No Action Indicated (NAI) |
| DUSA Pharmaceuticals, Inc. | Devices | 09/08/2023 | Voluntary Action Indicated (VAI) |
| East West Imports, Inc. | Food/Cosmetics | 02/01/2023 | Voluntary Action Indicated (VAI) |
| Freedom Bakery | Food/Cosmetics | 05/23/2023 | Voluntary Action Indicated (VAI) |
| Fresenius Medical Care Holdings, Inc. | Devices | 08/02/2023 | Official Action Indicated (OAI) |
| Hemedex, Inc. | Devices | 02/17/2023 | No Action Indicated (NAI) |
| InfuTronix, LLC | Devices | 08/16/2023 | Official Action Indicated (OAI) |
| InfuTronix, LLC | Devices | 08/16/2023 | Voluntary Action Indicated (VAI) |
| Ipsen Bioscience, Inc. | Drugs | 10/19/2023 | No Action Indicated (NAI) |
| Ishitani Corporation | Food/Cosmetics | 08/17/2023 | Voluntary Action Indicated (VAI) |
| Italian Ready Meals | Food/Cosmetics | 03/17/2023 | No Action Indicated (NAI) |
| Joseph's Industrial Catering, Corporation | Food/Cosmetics | 06/06/2023 | Voluntary Action Indicated (VAI) |
| Karyopharm Therapeutics, Inc. | Drugs | 03/15/2023 | No Action Indicated (NAI) |
| Lake Boone Ice Company, LLC. | Food/Cosmetics | 11/08/2023 | No Action Indicated (NAI) |
| LeMaitre Vascular, Inc. | Devices | 05/16/2023 | Voluntary Action Indicated (VAI) |
| Len's Coffee, LLC | Food/Cosmetics | 08/22/2023 | No Action Indicated (NAI) |
| Lineage Logistics | Food/Cosmetics | 01/17/2023 | No Action Indicated (NAI) |
| Lumicell, Inc. | Devices | 08/18/2023 | Voluntary Action Indicated (VAI) |
| Lumicell, Inc. | Devices | 10/16/2023 | No Action Indicated (NAI) |
| Marks Wholesale, Inc. | Food/Cosmetics | 04/27/2023 | No Action Indicated (NAI) |
| Med Pen Concepts, LLC | Devices | 06/14/2023 | Voluntary Action Indicated (VAI) |
| Monogram Foods, LLC | Food/Cosmetics | 05/04/2023 | No Action Indicated (NAI) |
| Navada Imports | Food/Cosmetics | 01/10/2023 | Voluntary Action Indicated (VAI) |
| New England Cryogenic Center, Inc. | Biologics | 07/18/2023 | No Action Indicated (NAI) |
| Ocular Therapeutix, Inc. | Drugs | 11/09/2023 | No Action Indicated (NAI) |
| Perceptive Informatics, LLC | Drugs | 06/14/2023 | No Action Indicated (NAI) |
| Philips North America | Devices | 12/13/2023 | Voluntary Action Indicated (VAI) |
| Reily Foods Company | Food/Cosmetics | 07/05/2023 | No Action Indicated (NAI) |
| Safecor Health, LLC | Drugs | 03/16/2023 | Official Action Indicated (OAI) |
| Sartorius Stedim North America, Inc. | Drugs | 06/23/2023 | Voluntary Action Indicated (VAI) |
| TeleMed Systems | Devices | 06/09/2023 | Voluntary Action Indicated (VAI) |
| The Dough Connection Corporation | Food/Cosmetics | 12/19/2023 | Voluntary Action Indicated (VAI) |
| The TJX Companies, Inc. | Food/Cosmetics | 10/26/2023 | No Action Indicated (NAI) |
| True World Food Boston, LLC | Food/Cosmetics | 07/07/2023 | No Action Indicated (NAI) |
| Trustee, Inc. | Food/Cosmetics | 12/20/2023 | No Action Indicated (NAI) |
| Vericel Corporation | Biologics | 07/21/2023 | Voluntary Action Indicated (VAI) |
| Vericel Corporation | Devices | 07/21/2023 | No Action Indicated (NAI) |
| Victoria Gourmet, Inc. | Food/Cosmetics | 01/27/2023 | No Action Indicated (NAI) |
| Walden Local Meat Storage | Food/Cosmetics | 10/11/2023 | No Action Indicated (NAI) |
| Wellness Pet, LLC | Veterinary | 12/13/2023 | No Action Indicated (NAI) |
| Whitmore Family Enterprises, LLC | Food/Cosmetics | 05/19/2023 | Voluntary Action Indicated (VAI) |
| Zyno Medical, LLC | Devices | 08/16/2023 | Official Action Indicated (OAI) |
| Zyno Medical, LLC | Devices | 08/16/2023 | Voluntary Action Indicated (VAI) |
| dnata US Inflight Catering, LLC | Food/Cosmetics | 01/18/2023 | Voluntary Action Indicated (VAI) |
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