There were 46 companies in cities associated with Middlesex County, Massachusetts, that received 49 FDA inspections in 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 24.6% decrease from the number of companies inspected in the previous year, when 61 companies received 63 inspections.
Most of the companies inspected at the time were involved in the Devices sector. The second most common type of company inspected period worked in the Food and Cosmetics sector.
There were 27 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (58.7%). 15 should take voluntary action to correct the organization’s management operations (32.6%). Additionally, four companies had to take regulatory and/or administrative actions (8.7%).
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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Result |
|---|---|---|---|
| Accardi Foods, Inc. | Food and Cosmetics | 01/31/2024 | No Action Indicated (NAI) |
| Avania, LLC | Devices | 03/14/2024 | No Action Indicated (NAI) |
| BRIX Sugar Bakery, Inc. | Food and Cosmetics | 04/10/2024 | No Action Indicated (NAI) |
| Beaver Visitec International, Inc. | Devices | 09/18/2024 | Voluntary Action Indicated (VAI) |
| Boston IVF | Biologics | 09/19/2024 | No Action Indicated (NAI) |
| Boston Scientific Corporation | Devices | 11/26/2024 | Voluntary Action Indicated (VAI) |
| Box Mill Farm | Food and Cosmetics | 03/04/2024 | No Action Indicated (NAI) |
| Cambridge Interventional, LLC | Devices | 02/14/2024 | No Action Indicated (NAI) |
| ColdSnap, Corp. | Food and Cosmetics | 02/16/2024 | No Action Indicated (NAI) |
| Covis Pharma GmBH | Drugs | 09/19/2024 | No Action Indicated (NAI) |
| DeMoulas Supermarket, Inc. | Food and Cosmetics | 09/10/2024 | No Action Indicated (NAI) |
| Edelweiss Enterprises, Inc. | Food and Cosmetics | 12/02/2024 | Voluntary Action Indicated (VAI) |
| Empatica, Inc. | Devices | 01/31/2024 | No Action Indicated (NAI) |
| Fertility Centers Of New England | Biologics | 09/18/2024 | No Action Indicated (NAI) |
| Fresenius Medical Care Holdings, Inc. | Devices | 10/16/2024 | Official Action Indicated (OAI) |
| Genzyme Corporation | Drugs | 07/09/2024 | Official Action Indicated (OAI) |
| Global Organics, Ltd. | Food and Cosmetics | 07/17/2024 | No Action Indicated (NAI) |
| Helios Biomedical | Devices | 06/27/2024 | No Action Indicated (NAI) |
| Hologic, Inc. | Devices | 09/24/2024 | Official Action Indicated (OAI) |
| Iggy’s Bread, Ltd. | Food and Cosmetics | 02/14/2024 | No Action Indicated (NAI) |
| InfraRedX, Inc. | Devices | 01/09/2024 | No Action Indicated (NAI) |
| Lahey Clinic Hospital, Inc. | Biologics | 06/05/2024 | No Action Indicated (NAI) |
| Mannkind Corporation | Devices | 10/03/2024 | Voluntary Action Indicated (VAI) |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Official Action Indicated (OAI) |
| Medtronic, Inc. | Devices | 08/09/2024 | No Action Indicated (NAI) |
| NanoEnTek America, Inc. | Devices | 03/01/2024 | Voluntary Action Indicated (VAI) |
| Nasoya Foods USA, LLC | Food and Cosmetics | 03/04/2024 | Voluntary Action Indicated (VAI) |
| Navada Imports | Food and Cosmetics | 04/26/2024 | Voluntary Action Indicated (VAI) |
| Perceptive Informatics, LLC | Drugs | 01/18/2024 | No Action Indicated (NAI) |
| Perceptive Informatics, LLC | Drugs | 07/10/2024 | No Action Indicated (NAI) |
| Perceptive Informatics, LLC | Drugs | 10/01/2024 | No Action Indicated (NAI) |
| Philips Ultrasound, Inc. | Devices | 08/08/2024 | Voluntary Action Indicated (VAI) |
| QSA Global, Inc. | Devices | 05/21/2024 | No Action Indicated (NAI) |
| Rohtstein Corporation | Food and Cosmetics | 05/16/2024 | Voluntary Action Indicated (VAI) |
| Safecor Health, LLC | Drugs | 06/24/2024 | Voluntary Action Indicated (VAI) |
| Sinco, Inc. | Food and Cosmetics | 05/06/2024 | No Action Indicated (NAI) |
| Spectra Medical Devices, LLC | Devices | 04/25/2024 | Voluntary Action Indicated (VAI) |
| Sumitomo Pharma America, Inc. | Drugs | 08/02/2024 | No Action Indicated (NAI) |
| Takeda Pharmaceuticals USA | Drugs | 03/22/2024 | No Action Indicated (NAI) |
| Takeda Pharmaceuticals USA | Drugs | 10/16/2024 | No Action Indicated (NAI) |
| Tecomet, Inc. | Devices | 11/12/2024 | Voluntary Action Indicated (VAI) |
| The Leavitt Corporation | Food and Cosmetics | 05/09/2024 | No Action Indicated (NAI) |
| The Superior Nut Company, Inc. | Food and Cosmetics | 12/13/2024 | Voluntary Action Indicated (VAI) |
| Thea Pharma, Inc. | Biologics | 06/06/2024 | No Action Indicated (NAI) |
| True World Food Boston, LLC | Food and Cosmetics | 09/16/2024 | No Action Indicated (NAI) |
| Turn Two Corporation | Food and Cosmetics | 12/03/2024 | No Action Indicated (NAI) |
| Vericel Corporation | Devices | 09/25/2024 | Voluntary Action Indicated (VAI) |
| Weruva International, Inc. | Veterinary | 02/20/2024 | No Action Indicated (NAI) |
| scPharmaceuticals, Inc. | Devices | 01/25/2024 | Voluntary Action Indicated (VAI) |
| scPharmaceuticals, Inc. | Drugs | 01/25/2024 | Voluntary Action Indicated (VAI) |



