Nola Reporter

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

This is a 50% decrease from the number of companies cited in the previous year.

Of the 19 citations issued, the most common citations include:

• The IRB did not follow its written procedure for conducting its initial and continuing review of research.
• The IRB did not follow written procedures for ensuring prompt reporting to appropriate institutional officials and the FDA of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB.
• The IRB did not follow written procedures for ensuring prompt reporting to appropriate institutional officials and the FDA of any suspension or termination of IRB approval .

The companies cited were involved in either Food and Cosmetics, Biologics, Devices, or Drugs sectors.

Both companies cited had to take regulatory and/or administrative actions.

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
Freshy Foods, LLC	Food and Cosmetics	07/14/2023	Manufacturing, processing, packing, holding - Controls
Louisiana State University Health Sciences Center	Biologics	07/26/2023	Initial and continuing reviews
Louisiana State University Health Sciences Center	Biologics	07/26/2023	Prompt reporting of noncompliance
Louisiana State University Health Sciences Center	Biologics	07/26/2023	Reporting of suspension/termination
Louisiana State University Health Sciences Center	Biologics	07/26/2023	Continuing review
Louisiana State University Health Sciences Center	Biologics	07/26/2023	Statement of reasons
Louisiana State University Health Sciences Center	Biologics	07/26/2023	Minutes of IRB meetings
Louisiana State University Health Sciences Center	Devices	07/26/2023	Initial and continuing reviews
Louisiana State University Health Sciences Center	Devices	07/26/2023	Prompt reporting of noncompliance
Louisiana State University Health Sciences Center	Devices	07/26/2023	Reporting of suspension/termination
Louisiana State University Health Sciences Center	Devices	07/26/2023	Continuing review
Louisiana State University Health Sciences Center	Devices	07/26/2023	Statement of reasons
Louisiana State University Health Sciences Center	Devices	07/26/2023	Minutes of IRB meetings
Louisiana State University Health Sciences Center	Drugs	07/26/2023	Initial and continuing reviews
Louisiana State University Health Sciences Center	Drugs	07/26/2023	Prompt reporting of noncompliance
Louisiana State University Health Sciences Center	Drugs	07/26/2023	Reporting of suspension/termination
Louisiana State University Health Sciences Center	Drugs	07/26/2023	Continuing review
Louisiana State University Health Sciences Center	Drugs	07/26/2023	Statement of reasons
Louisiana State University Health Sciences Center	Drugs	07/26/2023	Minutes of IRB meetings