North Middlesex Times

There were 12 companies in cities associated with Middlesex County that received FDA citations as a result of 12 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 42.9% decrease from the number of companies cited in the previous year.

Of the 24 citations issued, the most common citation was 'You did not develop an FSVP'.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the 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
Amware Fulfillment Services, Inc.	Drugs	06/22/2023	Training--operations, GMPs, written procedures
E-Beam Services, Inc.	Devices	04/27/2023	Change records, content
E-Beam Services, Inc.	Devices	04/27/2023	DHR content
Gurudev Imports, Inc.	Food and Cosmetics	01/18/2023	Hazard analysis biological, chemical, physical
Gurudev Imports, Inc.	Food and Cosmetics	01/18/2023	Verification activity frequency
Gurudev Imports, Inc.	Food and Cosmetics	01/18/2023	Verification activity before import, periodically
Henry's United, LLC	Food and Cosmetics	07/20/2023	Develop FSVP
Ingen Orthopedics, LLC	Devices	05/03/2023	Training - Lack of or inadequate procedures
Ingen Orthopedics, LLC	Devices	05/03/2023	Document review, approval documentation
Interstate Caterers, Inc.	Food and Cosmetics	12/01/2023	Cleaning and sanitizing substances - Safe and adequate
Interstate Caterers, Inc.	Food and Cosmetics	12/01/2023	Food safety plan
Interstate Caterers, Inc.	Food and Cosmetics	12/01/2023	No HACCP plan
Interstate Caterers, Inc.	Food and Cosmetics	12/01/2023	Calibration - adequacy
Kauffman Holdings	Food and Cosmetics	02/09/2023	Develop FSVP
Kauffman Holdings	Food and Cosmetics	02/09/2023	Evaluation - performance, risk
Kauffman Holdings	Food and Cosmetics	02/09/2023	Approved supplier procedures - importer established
Monsurat Mustapha	Food and Cosmetics	01/26/2023	Very small importer assurances, supplier
Nirwana Foods, LLC	Food and Cosmetics	04/11/2023	Sanitation of non-food-contact surfaces - Manner and frequency
Nirwana Foods, LLC	Food and Cosmetics	04/11/2023	Sanitary facilities and controls
Nirwana Foods, LLC	Food and Cosmetics	04/11/2023	Manufacturing, processing, packing, holding - Controls
Nirwana Foods, LLC	Food and Cosmetics	04/11/2023	Food safety plan
Roshen USA, CORP	Food and Cosmetics	03/21/2023	Develop FSVP
SLT Foods, Inc.	Food and Cosmetics	04/21/2023	Develop FSVP
Universal Protein Supplements Corporation	Food and Cosmetics	05/01/2023	Manufacturing operations - prevent contamination