NYC Gazette

There were two companies in a city associated with New York County that received FDA citations as a result of two inspections conducted in the county over the third quarter of 2024, 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 quarter.

The citations in the county include:

• Written standard operating procedures including all steps to be followed in the storage of blood and blood components for allogeneic transfusion were not always established, maintained and followed.
• Records are not concurrently maintained with the performance of each significant step in the distribution of each unit of blood and blood components so that all steps can be clearly traced.
• Failure to maintain general records.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Mount Sinai Hospital Blood Bank	Biologics	07/02/2024	Establish, maintain and follow manufacturing SOPs
Mount Sinai Hospital Blood Bank	Biologics	07/02/2024	Concurrent documentation
Mount Sinai Hospital Blood Bank	Biologics	07/02/2024	Required records
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