Atlantic County Times

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

This is a 100% increase over the number of companies cited in the previous year.

Of the 13 citations issued, the most common citations include:

• The IRB allowed a member to participate in the IRB's continuing review of a project in which the member had a conflicting interest.
• The IRB used an expedited review procedure for research appearing in an FDA list of categories eligible for expedited review, but the reviewer did not find the research involved no more than minimal risk to the subjects.
• Records have not been prepared of all continuing review activities.

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
AtlantiCare Regional Medical Center IRB	Biologics	02/10/2023	Conflict of interest
AtlantiCare Regional Medical Center IRB	Biologics	02/10/2023	No more than minimal risk
AtlantiCare Regional Medical Center IRB	Biologics	02/10/2023	Records of continuing review
AtlantiCare Regional Medical Center IRB	Devices	02/10/2023	Conflict of interest
AtlantiCare Regional Medical Center IRB	Devices	02/10/2023	No more than minimal risk
AtlantiCare Regional Medical Center IRB	Devices	02/10/2023	Records of continuing review
AtlantiCare Regional Medical Center IRB	Drugs	02/10/2023	Conflict of interest
AtlantiCare Regional Medical Center IRB	Drugs	02/10/2023	No more than minimal risk
AtlantiCare Regional Medical Center IRB	Drugs	02/10/2023	Records of continuing review
B. F. Mazzeo Fruit & Produce, Inc.	Food and Cosmetics	10/20/2023	Food safety plan
Formica Freitag, LLC	Food and Cosmetics	09/15/2023	Personnel
Steels Fudge, Inc.	Food and Cosmetics	12/14/2023	Sanitation of food-contact surfaces - Frequency
Steels Fudge, Inc.	Food and Cosmetics	12/14/2023	Manufacturing, processing, packing, holding - Controls