How many companies in cities in Middlesex County received FDA inspections in 2023?

How many companies in cities in Middlesex County received FDA inspections in 2023?
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration — Official Website
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There were 59 companies in cities associated with Middlesex County, Massachusetts, that received 60 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

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.

Companies Located in Cities Within Middlesex County and Their Inspection Results
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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