Metro West Times

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.

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)