How many companies in cities across Richmond County received FDA citations in 2024?

How many companies in cities across Richmond County received FDA citations in 2024?
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA — Official Website
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There were 29 companies in cities associated with Richmond County that received FDA citations as a result of 31 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 6.5% decrease from the number of companies cited in the previous year.

Of the 80 citations issued, the most common citation was ‘You did not develop an FSVP’.

Most of the companies cited were involved in the Biologics sector. The second most common type of company cited in the time period worked in the Food and Cosmetics sector.

Of the companies cited, 29 should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (3.4%).

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.

According to its website, 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.

Companies Located Within Richmond County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
3D Smile USA, Inc. Devices 03/29/2024 Lack of Written MDR Procedures
3D Smile USA, Inc. Devices 03/29/2024 Documentation
3D Smile USA, Inc. Devices 03/29/2024 Complaints
Aeye Health, Inc. Devices 03/15/2024 Lack of Written MDR Procedures
Applevalley Organics, Corporation, Inc. Veterinary 11/07/2024 Develop FSVP
Billybey Marina Services, LLC Food and Cosmetics 12/19/2024 Prevention of contamination
Billybey Marina Services, LLC Food and Cosmetics 12/19/2024 Signs for non-potable water
Billybey Marina Services, LLC Food and Cosmetics 01/23/2024 Prevention of contamination
California Cryobank, LLC Biologics 06/07/2024 Abbreviated procedure
Chelsea Fertility NYC Biologics 11/22/2024 Determination based on screening and testing
Chelsea Fertility NYC Biologics 11/22/2024 Accurate, indelible, legible
Chelsea Fertility NYC Biologics 11/22/2024 Shipped but not kept in quarantine
Chelsea Fertility NYC Biologics 11/22/2024 Specimen collections not timely
Emily A. DiMango, M.D. Drugs 08/13/2024 Safety Reports – Serious Events
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
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
Global Fertility & Genetics Biologics 12/09/2024 Testing, screening, donor eligibility procedures
Global Fertility & Genetics Biologics 12/09/2024 Determination based on screening and testing
Global Fertility & Genetics Biologics 12/09/2024 Labeled re: biohazard, risks, test results
Halo Innovations, Inc. Devices 12/06/2024 Design plans – Lack of or inadequate
Halo Innovations, Inc. Devices 12/06/2024 Design verification – documentation
Halo Innovations, Inc. Devices 12/06/2024 Documentation
HornBlower Cruises and Events, LLC Food and Cosmetics 09/17/2024 Qualifications of individuals
HornBlower Cruises and Events, LLC Food and Cosmetics 09/17/2024 Personnel
HornBlower Cruises and Events, LLC Food and Cosmetics 09/17/2024 Cleaning and sanitizing substances – Safe and adequate
HornBlower Cruises and Events, LLC Food and Cosmetics 09/17/2024 Manufacturing, processing, packing, holding – Controls
HornBlower Cruises and Events, LLC Food and Cosmetics 09/17/2024 Backflow protection
HornBlower Cruises and Events, LLC Food and Cosmetics 09/17/2024 Outlets for non-potable water
HornBlower Cruises and Events, LLC Food and Cosmetics 09/17/2024 Prevention of contamination
HornBlower Cruises and Events, LLC Food and Cosmetics 09/17/2024 Signs for non-potable water
Imagen Technologies, Inc. Devices 01/25/2024 Lack of or inadequate complaint procedures
J & H Imports Services, Corp. Food and Cosmetics 01/29/2024 Develop FSVP
J & H Imports Services, Corp. Food and Cosmetics 01/29/2024 Hazard analysis biological, chemical, physical
J & H Imports Services, Corp. Food and Cosmetics 01/29/2024 Reevaluate – document
J & H Imports Services, Corp. Food and Cosmetics 04/12/2024 Develop FSVP
J & H Imports Services, Corp. Food and Cosmetics 04/12/2024 Hazard analysis biological, chemical, physical
J & H Imports Services, Corp. Food and Cosmetics 04/12/2024 Evaluation – performance, risk
J & H Imports Services, Corp. Food and Cosmetics 04/12/2024 Corrective actions – take, 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
Kirby Offshore Marine, LLC Food and Cosmetics 12/16/2024 Prevention of contamination
Lenox Hill Hospital Biologics 04/01/2024 Concurrent documentation
Lenox Hill Hospital Biologics 04/01/2024 Required records
Mark V. DiBuono, M.D. Drugs 05/31/2024 FD-1572, protocol compliance
Mount Sinai Hospital Blood Bank Biologics 07/02/2024 Establish, maintain and follow manufacturing SOPs
Mount Sinai Hospital Blood Bank Biologics 07/02/2024 Concurrent documentation
Mount Sinai Hospital Blood Bank Biologics 07/02/2024 Required records
NYU Langone Health Hospital Biologics 09/26/2024 Establish, maintain and follow manufacturing SOPs
NYU Langone Health Hospital Biologics 09/26/2024 Establishment of spec., standards, and test procedures
Neil S. Sadick, M.D. Drugs 10/09/2024 FD-1572, protocol compliance
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
Promade POC Center for Complex Orthopedic Solutions at HHS Devices 01/18/2024 DHR – not or inadequately maintained
Repro Lab Biologics 11/19/2024 Abbreviated procedure
Repro Lab Biologics 11/19/2024 SOP for release; reactive for CMV
Rick’s Picks USA, LLC Food and Cosmetics 07/18/2024 Develop FSVP
The Center For Human Reproduction Biologics 05/01/2024 Testing, screening, donor eligibility procedures
The Center For Human Reproduction Biologics 05/01/2024 Determination based on screening and testing
The Center For Human Reproduction Biologics 05/01/2024 Responsible person to determine, document
The Center For Human Reproduction Biologics 05/01/2024 Name and personal info on accompanying records
The Center For Human Reproduction Biologics 05/01/2024 Accurate, indelible, legible
The Center For Human Reproduction Biologics 05/01/2024 Labeled re: biohazard, risks, test results
Tzumi Electronics, LLC Veterinary 02/22/2024 Develop FSVP
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Qualifications of individuals
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Personnel
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Plant construction and design
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Pest control
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Sanitary facilities and controls
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Hazard analysis – Identification of hazard
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Allergen preventive controls – Implement
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Process preventive controls – Implement
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Sanitation preventive controls – Implement
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Sanitation preventive controls – Appropriate (Adequate)
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Supply-chain program – Implement


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