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 fourth 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:

• The abbreviated donor screening procedure did not determine and document changes in the donor's medical history that would make the donor ineligible.
• A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not established.
• You did not develop an FSVP.

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
Applevalley Organics, Corporation, Inc.	Veterinary	11/07/2024	Develop FSVP
Repro Lab	Biologics	11/19/2024	Abbreviated procedure
Repro Lab	Biologics	11/19/2024	SOP for release; reactive for CMV