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.
| 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) |
