NYC Gazette

There was one company in a city associated with Richmond County that received FDA citations as a result of one inspection conducted in the county in May, 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 month.

The citations in the county include:

• You did not establish and maintain procedures for testing, screening and determining the eligibility of HCT/P donors.
• HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
• The eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.

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
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