How many FDA citations were issued in cities within Suffolk County in January

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

By Suffolk Reporter

Feb 1, 2024

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

This is a 33.3% decrease from the number of companies cited in the previous month.

The citations in the county include:

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use.
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Both companies cited were involved in either Drugs or Biologics sectors.

Both 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 Suffolk County Cities and the citations they received in January

Company Name	Area of Business	Inspection Date	Issue Cited
Radienz Living, LLC	Drugs	01/11/2024	Equipment Design, Size and Location
Radienz Living, LLC	Drugs	01/11/2024	Written procedures not established/followed
Radienz Living, LLC	Drugs	01/11/2024	Computer control of master formula records
Radienz Living, LLC	Drugs	01/11/2024	Control procedures to monitor and validate performance
Radienz Living, LLC	Drugs	01/11/2024	Storage under appropriate conditions
Radienz Living, LLC	Drugs	01/11/2024	Batch production and Batch Control Record Requirements
U. S. Department of Veterans Affairs, Northport VA Medical Center	Biologics	01/09/2024	Establish, maintain and follow manufacturing SOPs
U. S. Department of Veterans Affairs, Northport VA Medical Center	Biologics	01/09/2024	Required records