NYC Gazette

There were four companies in a city associated with Queens County that received FDA citations as a result of four inspections conducted in the county over the second quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 20% decrease from the number of companies cited in the previous quarter.

Of the 11 citations issued, the most common citations were 'You did not establish and maintain procedures for testing, screening and determining the eligibility of HCT/P donors' and 'HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend, a statement warning of communicable disease risks and a statement warning of the reactive test results'.

All 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.

Company Name	Area of Business	Inspection Date	Issue Cited
American Infertility of New York, P.C.	Biologics	05/01/2024	Testing, screening, donor eligibility procedures
American Infertility of New York, P.C.	Biologics	05/01/2024	Determination based on screening and testing
American Infertility of New York, P.C.	Biologics	05/01/2024	Responsible person to determine, document
American Infertility of New York, P.C.	Biologics	05/01/2024	Name and personal info on accompanying records
American Infertility of New York, P.C.	Biologics	05/01/2024	Accurate, indelible, legible
American Infertility of New York, P.C.	Biologics	05/01/2024	Labeled re: biohazard, risks, test results
California Cryobank, LLC	Biologics	06/07/2024	Abbreviated procedure
Extend Fertility, LLC	Biologics	04/19/2024	Testing, screening, donor eligibility procedures
Extend Fertility, LLC	Biologics	04/19/2024	Labeled re: biohazard, risks, test results
Lenox Hill Hospital	Biologics	04/01/2024	Concurrent documentation
Lenox Hill Hospital	Biologics	04/01/2024	Required records