NYC Gazette

There was one company in a city associated with Bronx County that received FDA citations as a result of one inspection conducted in the county in September, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous month.

The citations in the county were 'Written standard operating procedures including all steps to be followed in the processing, storage and distribution of blood and blood components for allogeneic transfusion were not always established, maintained and followed' and 'Failure to establish scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective'.

The company cited should take a voluntary action to correct its 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
NYU Langone Hospitals	Biologics	09/26/2024	Establish, maintain and follow manufacturing SOPs
NYU Langone Hospitals	Biologics	09/26/2024	Establishment of spec., standards, and test procedures