How many FDA citations were issued in cities within Nassau County in March

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

By Nassau Standard

Apr 1, 2024

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

This is a 200% increase over the number of companies cited in the previous month.

The citations in the county include:

HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
You did not take a reasonable measure or precaution related to personnel practices.
You did not maintain your plant in a clean and sanitary condition and in adequate repair.

Most of the companies cited were involved in the Biologics 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.

Companies located within Nassau County Cities and the citations they received in March

Company Name	Area of Business	Inspection Date	Issue Cited
Long Island Jewish Medical Center	Biologics	03/15/2024	Establish, maintain and follow manufacturing SOPs
Long Island Jewish Medical Center	Biologics	03/15/2024	Person performing, test results, interpretation
Long Island Jewish Medical Center	Biologics	03/15/2024	Required records
New York Cryo	Biologics	03/21/2024	Determination based on screening and testing
Zomick's Food Products, Ltd.	Food and Cosmetics	03/19/2024	Personnel
Zomick's Food Products, Ltd.	Food and Cosmetics	03/19/2024	Sanitary operations - Plant maintenance
Zomick's Food Products, Ltd.	Food and Cosmetics	03/19/2024	Sanitary operations - Plant sanitation
Zomick's Food Products, Ltd.	Food and Cosmetics	03/19/2024	Pest control
Zomick's Food Products, Ltd.	Food and Cosmetics	03/19/2024	Equipment and utensils - Design and maintenance
Zomick's Food Products, Ltd.	Food and Cosmetics	03/19/2024	Manufacturing, processing, packing, holding - Controls