Union County Review

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

This is a 16.7% increase over the number of companies cited in the previous year.

Of the 26 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.

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
Almark Tool & Manufacturing Company, Inc.	Devices	02/07/2023	Lack of Written MDR Procedures
Almark Tool & Manufacturing Company, Inc.	Devices	02/07/2023	Training - Lack of or inadequate procedures
Almark Tool & Manufacturing Company, Inc.	Devices	02/07/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Almark Tool & Manufacturing Company, Inc.	Devices	02/07/2023	DMR - not or inadequately maintained
Almark Tool & Manufacturing Company, Inc.	Devices	02/07/2023	DHR - not or inadequately maintained
Almark Tool & Manufacturing Company, Inc.	Devices	02/07/2023	Lack of or inadequate complaint procedures
Atul J. Enterprises, LLC	Food and Cosmetics	03/24/2023	Personnel
Atul J. Enterprises, LLC	Food and Cosmetics	03/24/2023	Plant construction and design
Atul J. Enterprises, LLC	Food and Cosmetics	03/24/2023	Cleaning and sanitizing substances - Safe and adequate
Atul J. Enterprises, LLC	Food and Cosmetics	03/24/2023	Equipment and utensils - Design and maintenance
Atul J. Enterprises, LLC	Food and Cosmetics	03/24/2023	Food safety plan
Indian Foods & Spices, LLC	Food and Cosmetics	04/17/2023	Develop FSVP
Indian Foods & Spices, LLC	Food and Cosmetics	04/17/2023	Hazard analysis biological, chemical, physical
Indian Foods & Spices, LLC	Food and Cosmetics	04/17/2023	Evaluation - performance, risk
Indian Foods & Spices, LLC	Food and Cosmetics	04/17/2023	Approved supplier procedures - importer established
Indian Foods & Spices, LLC	Food and Cosmetics	04/17/2023	Verification activity assurance
International Coconut Corporation	Food and Cosmetics	06/27/2023	Sanitary facilities and controls
International Coconut Corporation	Food and Cosmetics	06/27/2023	Hazard analysis - Identification of hazard
International Coconut Corporation	Food and Cosmetics	06/27/2023	Process preventive controls - Implement
International Coconut Corporation	Food and Cosmetics	06/27/2023	Sanitation preventive controls - Appropriate (Adequate)
International Coconut Corporation	Food and Cosmetics	06/27/2023	Supply-chain program - Establish
LA Serranita Import and Export, LLC	Food and Cosmetics	04/19/2023	Develop FSVP
The Sperm and Embryo Bank of New Jersey, Inc.	Biologics	09/05/2023	Responsible person to determine, document
The Sperm and Embryo Bank of New Jersey, Inc.	Biologics	09/05/2023	Specimen collections not timely
The Sperm and Embryo Bank of New Jersey, Inc.	Biologics	09/05/2023	Reproductive cells or tissues-cell-associated CD
Twin City	Food and Cosmetics	08/02/2023	Develop FSVP