How many companies in cities in Middlesex County received FDA inspections in 2024?

How many companies in cities in Middlesex County received FDA inspections in 2024?
Vid Desai FDA’s Chief Information Officer — Official Website
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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.

Companies Located in Cities Within Middlesex County and Their Inspection Results
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)


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