West Essex News

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

This is a 20% decrease from the number of companies cited in the previous year.

The citations in the county include:

• Your hazard analysis did not identify a hazard that requires a control.
• You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
• You did not document that you promptly reevaluated a foreign supplier's performance or the risk posed by a food when you became aware of new information about the foreign supplier's performance or the risk posed by a food.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, seven should take voluntary actions to correct their managing operations (87.5%). Additionally, one company had to take regulatory and/or administrative actions (12.5%).

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
Bacik Company of NY, Inc.	Food and Cosmetics	04/25/2023	Verification activity - appropriate
Dara Food, LLC	Food and Cosmetics	01/20/2023	Hazard analysis biological, chemical, physical
Dara Food, LLC	Food and Cosmetics	01/20/2023	Evaluation - performance, risk
Dara Food, LLC	Food and Cosmetics	01/20/2023	Revaluate - new information
Dara Food, LLC	Food and Cosmetics	01/20/2023	Supplier verification - establish written procedures
Flying Food Group, LLC	Food and Cosmetics	08/09/2023	Hazard analysis - Identification of hazard
Flying Food Group, LLC	Food and Cosmetics	08/09/2023	Hazard analysis
Nasto's Ice Cream Company	Food and Cosmetics	05/22/2023	Food safety plan
Newark Beth Israel Medical Center - Blood Bank	Biologics	10/13/2023	Establish, maintain and follow manufacturing SOPs
Newark Beth Israel Medical Center - Blood Bank	Biologics	10/13/2023	Concurrent documentation
Parker Laboratories, Inc.	Drugs	06/14/2023	Reports of Analysis (Components)
Parker Laboratories, Inc.	Drugs	06/14/2023	Absence of Written Procedures
Parker Laboratories, Inc.	Drugs	06/14/2023	Lack of written stability program
Parker Laboratories, Inc.	Drugs	06/14/2023	Items to cover on annual reviews
Parker Laboratories, Inc.	Drugs	06/14/2023	Actual yield, % of theoretical yield
Parker Laboratories, Inc.	Devices	05/23/2023	Production and Process Change Procedures, lack of or Inad.
Parker Laboratories, Inc.	Devices	05/23/2023	Lack of or inadequate process validation
Parker Laboratories, Inc.	Devices	05/23/2023	Lack/Inad procedure-Monitoring/Control of Validated Proces
Parker Laboratories, Inc.	Devices	05/23/2023	Product rework documentation, DHR {see also 820.184}
Spice Import Export, Inc.	Food and Cosmetics	06/07/2023	Develop FSVP
Trin Jam Distributors, Inc.	Food and Cosmetics	09/29/2023	Hazard analysis - Conducted
Trin Jam Distributors, Inc.	Food and Cosmetics	09/29/2023	Signed and dated
Trin Jam Distributors, Inc.	Food and Cosmetics	09/29/2023	Calibration - adequacy
Trin Jam Distributors, Inc.	Food and Cosmetics	09/29/2023	Verification - corrective action
Trin Jam Distributors, Inc.	Food and Cosmetics	09/29/2023	Records - content