Merrimack Valley News

There were four companies in cities associated with Middlesex County that received FDA citations as a result of four inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 55.6% decrease from the number of companies cited in the previous quarter.

Of the 14 citations issued, the most common citations include:

• Procedures have not been adequately established to control product that does not conform to specified requirements.
• Procedures for corrective and preventive action have not been adequately established.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.

Most of the companies cited were involved in the Devices sector.

All of the companies cited should take voluntary actions to correct their managing operations.

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	Issue Cited
3-D Matrix, Inc.	Devices	10/18/2023	Documented evaluation
3-D Matrix, Inc.	Devices	10/18/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
3-D Matrix, Inc.	Devices	10/18/2023	Lack of or inadequate process validation
3-D Matrix, Inc.	Devices	10/18/2023	Nonconforming product, Lack of or inadequate procedures
3-D Matrix, Inc.	Devices	10/18/2023	Lack of or inadequate procedures
3-D Matrix, Inc.	Devices	10/18/2023	Lack of or inadequate procedures for handling
3-D Matrix, Inc.	Devices	10/18/2023	Lack of or inadequate complaint procedures
Brammer Bio MA, LLC	Biologics	12/19/2023	SOPs not followed / documented
Philips North America	Devices	12/13/2023	Nonconforming product, Lack of or inadequate procedures
Philips North America	Devices	12/13/2023	Lack of or inadequate procedures
Philips North America	Devices	12/13/2023	Lack of or inadequate complaint procedures
The Dough Connection Corporation	Food and Cosmetics	12/19/2023	Qualifications of individuals
The Dough Connection Corporation	Food and Cosmetics	12/19/2023	Pest control
The Dough Connection Corporation	Food and Cosmetics	12/19/2023	Food safety plan