Cities located in Richmond County saw FDA inspections of 79 companies in 2024

Cities located in Richmond County saw FDA inspections of 79 companies in 2024
Mark Raza Principal Deputy Chief Counsel - FDA — Official Website
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There were 79 companies in cities associated with Richmond County, New York, that received 81 FDA inspections in 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is an 11.2% decrease from the number of companies inspected in the previous year, when 89 companies received 89 inspections.

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

There were 49 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (62%). 30 should take voluntary action to correct the organization’s management operations (38%). Additionally, one company had to take regulatory and/or administrative actions (1.3%).

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 in Cities Within Richmond County and Their Inspection Results
Company Name Area of Business Inspection Date Result
3D Smile USA, Inc. Devices 03/29/2024 Voluntary Action Indicated (VAI)
Aeye Health, Inc. Devices 03/15/2024 Voluntary Action Indicated (VAI)
Alison M. Schram, M.D. Drugs 06/11/2024 No Action Indicated (NAI)
Amtrade, Inc. Food and Cosmetics 07/25/2024 No Action Indicated (NAI)
Applevalley Organics, Corporation, Inc. Veterinary 11/07/2024 Voluntary Action Indicated (VAI)
Beta Imports, LLC Food and Cosmetics 04/30/2024 No Action Indicated (NAI)
Billybey Marina Services, LLC Food and Cosmetics 01/23/2024 Voluntary Action Indicated (VAI)
Billybey Marina Services, LLC Food and Cosmetics 12/19/2024 Voluntary Action Indicated (VAI)
BonBon NYC, LLC. Food and Cosmetics 05/07/2024 No Action Indicated (NAI)
California Cryobank, LLC Biologics 06/07/2024 Voluntary Action Indicated (VAI)
Chelsea Fertility NYC Biologics 11/22/2024 Voluntary Action Indicated (VAI)
Claire L. Keating, M.D. Drugs 08/16/2024 No Action Indicated (NAI)
ComeBack Mobility, Inc. Devices 01/12/2024 No Action Indicated (NAI)
DiscCath, LLC Devices 01/04/2024 No Action Indicated (NAI)
Elite Naturel USA, LLC Food and Cosmetics 06/18/2024 No Action Indicated (NAI)
Emily A. DiMango, M.D. Drugs 08/13/2024 Voluntary Action Indicated (VAI)
Empire Medical Office, P.C. Biologics 05/28/2024 No Action Indicated (NAI)
Evoke Neuroscience, Inc. Devices 10/18/2024 No Action Indicated (NAI)
Extend Fertility, LLC Biologics 04/19/2024 Voluntary Action Indicated (VAI)
Eytan M. Stein, M.D. Drugs 03/29/2024 No Action Indicated (NAI)
Fertility New York, P.C. Biologics 02/12/2024 No Action Indicated (NAI)
Fevertree Food and Cosmetics 11/18/2024 No Action Indicated (NAI)
Fifi, Johanna, M.D. Devices 12/20/2024 No Action Indicated (NAI)
Foodmatch, Inc. Food and Cosmetics 05/06/2024 No Action Indicated (NAI)
Fromi Usa Food and Cosmetics 08/12/2024 No Action Indicated (NAI)
Generation Next Fertility Biologics 01/12/2024 Voluntary Action Indicated (VAI)
Global Fertility & Genetics Biologics 12/09/2024 Voluntary Action Indicated (VAI)
Halo Innovations, Inc. Devices 12/06/2024 Voluntary Action Indicated (VAI)
Harriet Kang, M.D. Drugs 02/20/2024 Voluntary Action Indicated (VAI)
Helena A. Yu, M.D. Drugs 01/16/2024 No Action Indicated (NAI)
HornBlower Cruises and Events, LLC Food and Cosmetics 09/17/2024 Voluntary Action Indicated (VAI)
Hu Products Food and Cosmetics 03/26/2024 No Action Indicated (NAI)
Imagen Technologies, Inc. Devices 01/25/2024 Voluntary Action Indicated (VAI)
Intra-Cellular Therapies, Inc. Drugs 07/31/2024 No Action Indicated (NAI)
J & H Imports Services, Corp. Food and Cosmetics 01/29/2024 Voluntary Action Indicated (VAI)
J & H Imports Services, Corp. Food and Cosmetics 04/12/2024 Official Action Indicated (OAI)
Jeffrey M. Steinberg, Incorporated The Fertility Institutes, New York, M.D. Biologics 05/13/2024 No Action Indicated (NAI)
Joe Mozz, Inc. Food and Cosmetics 02/08/2024 Voluntary Action Indicated (VAI)
Kirby Offshore Marine, LLC Food and Cosmetics 12/16/2024 Voluntary Action Indicated (VAI)
Komodo Health, Inc. Drugs 06/06/2024 No Action Indicated (NAI)
Kosmas Casey A. Paleos, M.D. Drugs 03/26/2024 No Action Indicated (NAI)
Lenox Hill Hospital Biologics 04/01/2024 Voluntary Action Indicated (VAI)
Manhattan Reproductive Medicine, PC Biologics 05/24/2024 No Action Indicated (NAI)
Maria L. Palomba, M.D. Biologics 04/08/2024 No Action Indicated (NAI)
Mark Foods, Inc. Food and Cosmetics 07/09/2024 No Action Indicated (NAI)
Mark V. DiBuono, M.D. Drugs 05/31/2024 Voluntary Action Indicated (VAI)
Mediterranea Italia, LLC Food and Cosmetics 09/18/2024 No Action Indicated (NAI)
Melone BROS, Inc. Food and Cosmetics 02/05/2024 No Action Indicated (NAI)
Michael A. Werner PC, M.D. Biologics 09/06/2024 No Action Indicated (NAI)
Mount Sinai Hospital Blood Bank Biologics 07/02/2024 Voluntary Action Indicated (VAI)
NYC Health + Hospitals/Bellevue Biologics 03/28/2024 No Action Indicated (NAI)
NYC In Vitro Fertilization, P.C. Biologics 02/27/2024 No Action Indicated (NAI)
NYU Langone Health Hospital Biologics 09/26/2024 Voluntary Action Indicated (VAI)
Neil S. Sadick, M.D. Drugs 10/09/2024 Voluntary Action Indicated (VAI)
Neurodynamics, Inc. Devices 02/28/2024 Voluntary Action Indicated (VAI)
New Hope Fertility Center Biologics 02/22/2024 Voluntary Action Indicated (VAI)
New Nan Fong Hong Trading, Inc. Food and Cosmetics 12/18/2024 No Action Indicated (NAI)
New York Blood Center Donor Center of NYBC, Inc. Biologics 06/24/2024 No Action Indicated (NAI)
New York Blood Center, Inc. Biologics 09/18/2024 No Action Indicated (NAI)
New York University Langone Fertility Center Biologics 04/17/2024 No Action Indicated (NAI)
Northwell Health Fertility NYC Biologics 03/19/2024 No Action Indicated (NAI)
Oatly, Inc. Food and Cosmetics 01/17/2024 No Action Indicated (NAI)
Prakash Krishnan, M.D. Devices 02/29/2024 No Action Indicated (NAI)
Promade POC Center for Complex Orthopedic Solutions at HHS Devices 01/18/2024 Voluntary Action Indicated (VAI)
Reinauer Transportation Companies, LLC Food and Cosmetics 02/27/2024 No Action Indicated (NAI)
Repro Lab Biologics 11/19/2024 Voluntary Action Indicated (VAI)
Reproductive Medicine Associates of New York, LLP Biologics 01/31/2024 No Action Indicated (NAI)
Rick’s Picks USA, LLC Food and Cosmetics 07/18/2024 Voluntary Action Indicated (VAI)
Roman Health Ventures, Inc. Devices 09/05/2024 No Action Indicated (NAI)
Rona D. Yaeger, M.D. Drugs 03/12/2024 No Action Indicated (NAI)
Sojitz Corporation of America Veterinary 11/21/2024 No Action Indicated (NAI)
Syndax Pharmaceuticals, Inc. Drugs 08/22/2024 No Action Indicated (NAI)
TLKC Sigma, Inc. Food and Cosmetics 02/14/2024 No Action Indicated (NAI)
TMRW Biorepository New York, LLC Biologics 04/26/2024 No Action Indicated (NAI)
The Center For Human Reproduction Biologics 05/01/2024 Voluntary Action Indicated (VAI)
Traiteur DE Paris US, Inc. Food and Cosmetics 09/20/2024 No Action Indicated (NAI)
Tzumi Electronics, LLC Veterinary 02/22/2024 Voluntary Action Indicated (VAI)
VA New York Harbor Healthcare System Biologics 10/23/2024 No Action Indicated (NAI)
Viva Naturals, Inc. Food and Cosmetics 08/19/2024 No Action Indicated (NAI)
Yucca Tree, Corp. Food and Cosmetics 03/28/2024 Voluntary Action Indicated (VAI)
Zenith Foods, LLC Food and Cosmetics 09/30/2024 No Action Indicated (NAI)


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