NYC Gazette

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

This is a 16.7% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• You did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
• The eligibility of an HCT/P donor was not determined by a responsible person, based on results of donor screening and donor testing.
• HCT/Ps for which the applicable donor eligibility requirements were not met were not prominently labeled with the appropriate warning statements.

Most of the companies cited were involved in either Biologics or Food and Cosmetics sectors.

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
Billybey Marina Services, LLC	Food and Cosmetics	01/23/2024	Prevention of contamination
Generation Next Fertility	Biologics	01/12/2024	Design of procedures to ensure compliance
Generation Next Fertility	Biologics	01/12/2024	Accurate, indelible, legible
Generation Next Fertility	Biologics	01/12/2024	Risk factors, clinical evidence
J&H Imports Services Corporation	Food and Cosmetics	01/29/2024	Develop FSVP
J&H Imports Services Corporation	Food and Cosmetics	01/29/2024	Hazard analysis biological, chemical, physical
J&H Imports Services Corporation	Food and Cosmetics	01/29/2024	Reevaluate - document
Neurodynamics, Inc.	Devices	02/28/2024	Lack of Written MDR Procedures
New Hope Fertility Center	Biologics	02/22/2024	Testing, screening, donor eligibility procedures
New Hope Fertility Center	Biologics	02/22/2024	Responsible person to determine, document
New Hope Fertility Center	Biologics	02/22/2024	Eligibility not required--warning labels