Merrimack Valley News

There were 27 companies in cities associated with Middlesex County that received FDA citations as a result of 27 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 10% decrease from the number of companies cited in the previous year.

Of the 91 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.

Most of the companies cited were involved in the Devices sector. The second most common type of company cited in the time period worked in the the Food and Cosmetics sector.

Of the companies cited, 25 should take voluntary actions to correct their managing operations (92.6%). Additionally, four companies had to take regulatory and/or administrative actions (14.8%).

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	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
Anika Therapeutics, Inc.	Veterinary	08/09/2023	Equipment to control conditions
Anika Therapeutics, Inc.	Veterinary	08/09/2023	Written program not followed
Anika Therapeutics, Inc.	Veterinary	08/09/2023	Items to cover on annual reviews
Anika Therapeutics, Inc.	Veterinary	08/09/2023	Investigations of discrepancies, failures
AxioMed, LLC.	Devices	01/13/2023	Sponsor progress reports for significant risk study
Barkey Corporation	Devices	07/31/2023	Lack of or inadequate procedures
Barkey Corporation	Devices	07/31/2023	Lack of or inadequate procedures for storage.
Barkey Corporation	Devices	07/31/2023	Lack of or inadequate complaint procedures
Barrett Technology, LLC	Devices	03/07/2023	Quality audits - Lack of or inadequate procedures
Barrett Technology, LLC	Devices	03/07/2023	Training - Lack of or inadequate procedures
Barrett Technology, LLC	Devices	03/07/2023	Lack of or inadequate procedures
Barrett Technology, LLC	Devices	03/07/2023	Lack of or inadequate procedures for storage.
Barrett Technology, LLC	Devices	03/07/2023	Lack of or inadequate complaint procedures
Biosensics, LLC	Devices	04/07/2023	Evaluation of suppliers, contractors, etc., requirements
Biosensics, LLC	Devices	04/07/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Biosensics, LLC	Devices	04/07/2023	Lack of or inadequate procedures
Brammer Bio MA, LLC	Biologics	12/19/2023	SOPs not followed / documented
Candela Corporation	Devices	01/24/2023	Individual Report of Malfunction
Candela Corporation	Devices	01/24/2023	DHR - not or inadequately maintained
Candela Corporation	Devices	01/24/2023	Complaints
Conformis, Inc.	Devices	03/09/2023	Design input - Lack of or inadequate procedures
Conformis, Inc.	Devices	03/09/2023	Lack of or inadequate procedures
Conformis, Inc.	Devices	03/09/2023	Lack of or inadequate complaint procedures
Conformis, Inc.	Devices	03/09/2023	Investigation of device failures
DUSA Pharmaceuticals, Inc.	Devices	09/08/2023	Lack of or inadequate complaint procedures
East West Imports, Inc.	Food and Cosmetics	02/01/2023	No HACCP plan
Freedom Bakery	Food and Cosmetics	05/23/2023	Sanitary operations - Plant sanitation
Fresenius Medical Care Holdings, Inc.	Devices	08/02/2023	Report of risk to health
Fresenius Medical Care Holdings, Inc.	Devices	08/02/2023	Design validation- Lack of or inadequate procedures
Fresenius Medical Care Holdings, Inc.	Devices	08/02/2023	Evaluation of suppliers, contractors, etc., requirements
Fresenius Medical Care Holdings, Inc.	Devices	08/02/2023	Lack of or inadequate procedures
Fresenius Medical Care Holdings, Inc.	Devices	08/02/2023	Documentation
InfuTronix, LLC	Devices	08/16/2023	Report of Death or Serious Injury
InfuTronix, LLC	Devices	08/16/2023	Management review - defined interval, sufficient frequency
InfuTronix, LLC	Devices	08/16/2023	Lack of or inadequate procedures
InfuTronix, LLC	Devices	08/16/2023	Investigation of device failures
Ishitani Corporation	Food and Cosmetics	08/17/2023	Qualifications of individuals
Ishitani Corporation	Food and Cosmetics	08/17/2023	Sanitary operations - Plant sanitation
Ishitani Corporation	Food and Cosmetics	08/17/2023	Equipment and utensils - Design and maintenance
Joseph's Industrial Catering, Corporation	Food and Cosmetics	06/06/2023	Qualifications of individuals
Joseph's Industrial Catering, Corporation	Food and Cosmetics	06/06/2023	HACCP plan implementation
Joseph's Industrial Catering, Corporation	Food and Cosmetics	06/06/2023	Food safety hazards
Joseph's Industrial Catering, Corporation	Food and Cosmetics	06/06/2023	Corrective action per predetermined plan
Joseph's Industrial Catering, Corporation	Food and Cosmetics	06/06/2023	Sanitation monitoring
LeMaitre Vascular, Inc.	Devices	05/16/2023	Lack of or inadequate complaint procedures
Lumicell, Inc.	Devices	08/18/2023	Sponsors' general responsibilities
Navada Imports	Food and Cosmetics	01/10/2023	Develop FSVP
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
Safecor Health, LLC	Drugs	03/16/2023	Cleaning / Sanitizing / Maintenance
Safecor Health, LLC	Drugs	03/16/2023	Establish reliability of supplier's C of A
Safecor Health, LLC	Drugs	03/16/2023	Packaging line inspection before use
Safecor Health, LLC	Drugs	03/16/2023	Master production and control records, procedure
Safecor Health, LLC	Drugs	03/16/2023	Investigations of discrepancies, failures
Safecor Health, LLC	Drugs	03/16/2023	Complaint Investigation/Follow-Up Findings
Sartorius Stedim North America, Inc.	Drugs	06/23/2023	Procedures not in writing, fully followed
Sartorius Stedim North America, Inc.	Drugs	06/23/2023	Equipment Design, Size and Location
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
Vericel Corporation	Devices	07/21/2023	Environmental Monitoring System
Vericel Corporation	Devices	07/21/2023	Cleaning System
Vericel Corporation	Devices	07/21/2023	Written in-process control procedures
Vericel Corporation	Devices	07/21/2023	Procedures for sterile drug products
Vericel Corporation	Devices	07/21/2023	Acceptance criteria for sampling & testing
Vericel Corporation	Devices	07/21/2023	Investigations of discrepancies, failures
Vericel Corporation	Devices	07/21/2023	Design verification - Lack of or inadequate procedures
Vericel Corporation	Biologics	07/21/2023	Environmental Monitoring System
Vericel Corporation	Biologics	07/21/2023	Cleaning System
Vericel Corporation	Biologics	07/21/2023	Written in-process control procedures
Vericel Corporation	Biologics	07/21/2023	Procedures for sterile drug products
Vericel Corporation	Biologics	07/21/2023	Acceptance criteria for sampling & testing
Vericel Corporation	Biologics	07/21/2023	Investigations of discrepancies, failures
Vericel Corporation	Biologics	07/21/2023	Design verification - Lack of or inadequate procedures
Whitmore Family Enterprises, LLC	Food and Cosmetics	05/19/2023	Pest control
Whitmore Family Enterprises, LLC	Food and Cosmetics	05/19/2023	Process preventive controls - Implement
Whitmore Family Enterprises, LLC	Food and Cosmetics	05/19/2023	Sanitation preventive controls - Implement
Whitmore Family Enterprises, LLC	Food and Cosmetics	05/19/2023	Allergen preventive controls - Appropriate (Adequate)
Zyno Medical, LLC	Devices	08/16/2023	Individual Report of Malfunction
Zyno Medical, LLC	Devices	08/16/2023	Management review - defined interval, sufficient frequency
Zyno Medical, LLC	Devices	08/16/2023	Lack of or inadequate procedures
Zyno Medical, LLC	Devices	08/16/2023	Investigation of device failures
dnata US Inflight Catering, LLC	Food and Cosmetics	01/18/2023	Manufacturing, processing, packing, holding - Controls