NE Bergen News

There were 13 companies in cities associated with Bergen County that received FDA citations as a result of 13 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 43.5% decrease from the number of companies cited in the previous year.

Of the 40 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.

Of the companies cited, 11 should take voluntary actions to correct their managing operations (84.6%). Additionally, one company had to take regulatory and/or administrative actions (7.7%).

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
ARCA Continental	Food and Cosmetics	04/28/2023	Sanitary operations - Plant maintenance
ARCA Continental	Food and Cosmetics	04/28/2023	Pest control
Air Culinaire Worldwide	Food and Cosmetics	07/13/2023	Manufacturing, processing, packing, holding - Controls
Air Culinaire Worldwide	Food and Cosmetics	07/13/2023	Hazard analysis - Conducted
Air Culinaire Worldwide	Food and Cosmetics	07/13/2023	No HACCP plan
Castillo Distributors, Inc.	Food and Cosmetics	02/14/2023	Evaluation - performance, risk
Castillo Distributors, Inc.	Food and Cosmetics	02/14/2023	Supplier verification - establish written procedures
Castillo Distributors, Inc.	Food and Cosmetics	02/14/2023	Verification activity frequency
Castillo Distributors, Inc.	Food and Cosmetics	02/14/2023	Verification activity before import, periodically
Castillo Distributors, Inc.	Food and Cosmetics	02/14/2023	Investigate
Chemomouthpiece, LLC	Devices	09/19/2023	Management review - Lack of or inadequate procedures
Chemomouthpiece, LLC	Devices	09/19/2023	Purchasing controls, Lack of or inadequate procedures
Chemomouthpiece, LLC	Devices	09/19/2023	Lack of or inadequate procedures
Chemomouthpiece, LLC	Devices	09/19/2023	Lack of or inadequate complaint procedures
Esu Farms, LLC	Food and Cosmetics	01/27/2023	Develop FSVP
Jamol Laboratories, Inc.	Drugs	01/12/2023	Buildings of Suitable Size, Construction, Location
Jamol Laboratories, Inc.	Drugs	01/12/2023	Absence of Written Procedures
Jamol Laboratories, Inc.	Drugs	01/12/2023	Prepared for each batch, include complete information
Jamol Laboratories, Inc.	Drugs	01/12/2023	No written record of investigation
Julie Trading, LLC	Food and Cosmetics	04/25/2023	Develop FSVP
La Valle Foods USA	Food and Cosmetics	12/11/2023	Hazard analysis written
Media Plus, LLC	Devices	03/10/2023	Management review dates
Media Plus, LLC	Devices	03/10/2023	Quality Audits - defined intervals
Media Plus, LLC	Devices	03/10/2023	Design control - no procedures
Media Plus, LLC	Devices	03/10/2023	Purchasing controls, Lack of or inadequate procedures
Media Plus, LLC	Devices	03/10/2023	Lack of or inadequate DHR procedures
Sterling Seafood Corporation	Food and Cosmetics	01/05/2023	Develop FSVP
Suneet Mittal, M.D.	Devices	07/11/2023	Investigator non-compliance with agreement/plan/regulations
Titan Implants, Inc.	Devices	03/16/2023	Design validation- Lack of or inadequate procedures
Titan Implants, Inc.	Devices	03/16/2023	Environmental control Lack of or inadequate procedures
Titan Implants, Inc.	Devices	03/16/2023	Maintenance schedule, Lack of or inadequate schedule
Titan Implants, Inc.	Devices	03/16/2023	Lack of or inadequate process validation
Titan Implants, Inc.	Devices	03/16/2023	Lack of or inadequate procedures - Acceptance activities
Titan Implants, Inc.	Devices	03/16/2023	Nonconforming product, Lack of or inadequate procedures
Titan Implants, Inc.	Devices	03/16/2023	Documentation
Titan Implants, Inc.	Devices	03/16/2023	DHR - not or inadequately maintained
Titan Implants, Inc.	Devices	03/16/2023	DHR content
Titan Implants, Inc.	Devices	03/16/2023	Lack of or inadequate complaint procedures
University Reproductive Associates, P.C.	Biologics	01/19/2023	Design of procedures to ensure compliance
University Reproductive Associates, P.C.	Biologics	01/19/2023	Risk factors, clinical evidence