Merrimack Valley News

There were 20 companies in cities associated with Middlesex County, Massachusetts, that received 20 FDA inspections in the third quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 42.9% increase over the number of companies inspected in the previous quarter, when 14 companies received 14 inspections.

Most of the companies inspected at the time were involved in the Devices sector. The second most common type of company inspected worked in the Biologics sector.

There were 10 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (50%). Nine should take voluntary action to correct the organization's management operations (45%). Additionally, three companies had to take regulatory and/or administrative actions (15%).

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
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)
Barkey Corporation	Devices	07/31/2023	Voluntary Action Indicated (VAI)
Bedford Research Foundation, Inc.	Biologics	08/15/2023	No Action Indicated (NAI)
Brammer Bio MA, LLC	Biologics	08/30/2023	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)
Care Everywhere, LLC	Devices	08/16/2023	No Action Indicated (NAI)
DUSA Pharmaceuticals, Inc.	Devices	09/08/2023	Voluntary Action Indicated (VAI)
Fresenius Medical Care Holdings, Inc.	Devices	08/02/2023	Official Action Indicated (OAI)
InfuTronix, LLC	Devices	08/16/2023	Official Action Indicated (OAI)
InfuTronix, LLC	Devices	08/16/2023	Voluntary Action Indicated (VAI)
Ishitani Corporation	Food and Cosmetics	08/17/2023	Voluntary Action Indicated (VAI)
Len's Coffee, LLC	Food and Cosmetics	08/22/2023	No Action Indicated (NAI)
Lumicell, Inc.	Devices	08/18/2023	Voluntary Action Indicated (VAI)
New England Cryogenic Center, Inc.	Biologics	07/18/2023	No Action Indicated (NAI)
Reily Foods Company	Food and Cosmetics	07/05/2023	No Action Indicated (NAI)
True World Food Boston, LLC	Food and Cosmetics	07/07/2023	No Action Indicated (NAI)
Vericel Corporation	Biologics	07/21/2023	Voluntary Action Indicated (VAI)
Vericel Corporation	Devices	07/21/2023	No Action Indicated (NAI)
Zyno Medical, LLC	Devices	08/16/2023	Official Action Indicated (OAI)
Zyno Medical, LLC	Devices	08/16/2023	Voluntary Action Indicated (VAI)