NYC Gazette

There were seven companies in cities associated with Richmond County that received FDA citations as a result of seven 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% increase over the number of companies cited in the previous quarter.

Of the 25 citations issued, the most common citation was 'You did not have records documenting food hygiene and food safety training'.

Most of the companies cited were involved in the Food and Cosmetics 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
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
Joe Mozz, Inc.	Food and Cosmetics	02/08/2024	Qualifications of individuals
Joe Mozz, Inc.	Food and Cosmetics	02/08/2024	Sanitary operations - Plant sanitation
Joe Mozz, Inc.	Food and Cosmetics	02/08/2024	Manufacturing, processing, packing, holding - Controls
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
Port Richmond Bakery Corporation	Food and Cosmetics	03/28/2024	Qualifications of individuals
Port Richmond Bakery Corporation	Food and Cosmetics	03/28/2024	Personnel
Port Richmond Bakery Corporation	Food and Cosmetics	03/28/2024	Plant construction and design
Port Richmond Bakery Corporation	Food and Cosmetics	03/28/2024	Pest control
Port Richmond Bakery Corporation	Food and Cosmetics	03/28/2024	Sanitary facilities and controls
Port Richmond Bakery Corporation	Food and Cosmetics	03/28/2024	Hazard analysis - Identification of hazard
Port Richmond Bakery Corporation	Food and Cosmetics	03/28/2024	Allergen preventive controls - Implement
Port Richmond Bakery Corporation	Food and Cosmetics	03/28/2024	Process preventive controls - Implement
Port Richmond Bakery Corporation	Food and Cosmetics	03/28/2024	Sanitation preventive controls - Implement
Port Richmond Bakery Corporation	Food and Cosmetics	03/28/2024	Sanitation preventive controls - Appropriate (Adequate)
Port Richmond Bakery Corporation	Food and Cosmetics	03/28/2024	Supply-chain program - Implement