NYC Gazette

There were six companies in a city associated with New York County that received FDA citations as a result of six inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous quarter.

The citations in the county include:

• You did not establish and maintain procedures for testing, screening and determining the eligibility of HCT/P donors.
• Equipment used in the compatibility testing and storage and distribution of blood and blood components is not calibrated on a regularly scheduled basis as prescribed in the SOP Manual.
• Written standard operating procedures including all steps to be followed in the compatibility testing and distribution of blood and blood components for allogeneic transfusion were not always established and followed.

Most of the companies cited were involved in the Biologics sector. The second most common type of company cited in the time period worked in the .

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Eye Bank For Sight Restoration, Inc.	Biologics	11/13/2023	Adequate control, proper conditions
Eye Bank For Sight Restoration, Inc.	Biologics	11/13/2023	Use prior to verification
Eye Bank For Sight Restoration, Inc.	Biologics	11/13/2023	Accurate, indelible, legible
Eye Bank For Sight Restoration, Inc.	Biologics	11/13/2023	Records incomplete
Eye Bank For Sight Restoration, Inc.	Biologics	11/13/2023	Records maintained concurrently
New York Presbyterian Hospital-Columbia University Med. Center	Biologics	11/28/2023	Equipment observed, standardized, calibrated
New York Presbyterian Hospital-Columbia University Med. Center	Biologics	11/28/2023	Establish, maintain and follow manufacturing SOPs
New York Presbyterian Hospital-Columbia University Med. Center	Biologics	11/28/2023	Concurrent documentation
New York Presbyterian Hospital-Columbia University Med. Center	Biologics	11/28/2023	Required records
Pinnacle Fertility Labs New York	Biologics	12/14/2023	Testing, screening, donor eligibility procedures
Ports America, Inc.	Food and Cosmetics	10/10/2023	Prevention of contamination
Ports America, Inc.	Food and Cosmetics	10/10/2023	Signs for non-potable water
TMRW Life Sciences, Inc.	Devices	10/24/2023	DHR - not or inadequately maintained
Xtreem Pulse, LLC	Devices	10/13/2023	Design changes - Lack of or Inadequate Procedures
Xtreem Pulse, LLC	Devices	10/13/2023	Design history file
Xtreem Pulse, LLC	Devices	10/13/2023	Lack of or inadequate receiving acceptance procedures