Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 21.3% decrease from the number of companies inspected in the previous year, when 141 companies were inspected through 146 inspections.
Most of the companies inspected were involved in the Food/Cosmetics sector. The second most common type of company inspected in the time period worked in the Biologics sector.
There were 70 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (63.1%). 40 should take voluntary action to correct the organization's management operations (36%). Additionally, one company had to take regulatory and/or administrative actions (0.9%).
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.
Companies Located in Cities Within Bronx County and Their Inspection Results
| Company Name | Area of Business | Inspection Date | Result |
|---|---|---|---|
| 32 Bunga, Inc. | Food/Cosmetics | 10/11/2023 | No Action Indicated (NAI) |
| A & D Fortune, Inc. | Food/Cosmetics | 01/30/2023 | No Action Indicated (NAI) |
| A Life Wholesale | Food/Cosmetics | 10/10/2023 | Voluntary Action Indicated (VAI) |
| Aaron Gourmet Food Imports, Inc. | Food/Cosmetics | 06/01/2023 | Voluntary Action Indicated (VAI) |
| Adam F. Steinlauf, M.D. | Drugs | 02/28/2023 | No Action Indicated (NAI) |
| Adja Khady Food Distribution, Inc. | Food/Cosmetics | 08/22/2023 | Voluntary Action Indicated (VAI) |
| Aj Turco, Inc. | Food/Cosmetics | 09/28/2023 | No Action Indicated (NAI) |
| Alansu Global Trade | Food/Cosmetics | 01/25/2023 | No Action Indicated (NAI) |
| Alexander E. Drilon, M.D. | Drugs | 06/16/2023 | No Action Indicated (NAI) |
| Alexander M. Lesokhin, M.D. | Drugs | 04/12/2023 | Voluntary Action Indicated (VAI) |
| Americord Registry, LLC | Biologics | 01/13/2023 | Voluntary Action Indicated (VAI) |
| Amorino Trading, LLC | Food/Cosmetics | 03/02/2023 | Voluntary Action Indicated (VAI) |
| Applevalley Organics, Corporation, Inc. | Veterinary | 08/16/2023 | Voluntary Action Indicated (VAI) |
| Azra Raza, M.D. | Drugs | 10/12/2023 | No Action Indicated (NAI) |
| Baldor Specialty Foods, Inc. | Food/Cosmetics | 02/21/2023 | No Action Indicated (NAI) |
| BonBon NYC, LLC. | Food/Cosmetics | 02/24/2023 | Voluntary Action Indicated (VAI) |
| C. Kenneth Imports, Inc. | Food/Cosmetics | 09/13/2023 | No Action Indicated (NAI) |
| CAS BioSciences, LLC | Food/Cosmetics | 01/27/2023 | No Action Indicated (NAI) |
| Carive Imports, Inc. | Food/Cosmetics | 01/30/2023 | No Action Indicated (NAI) |
| Chocolat Moderne, LLC | Food/Cosmetics | 01/12/2023 | No Action Indicated (NAI) |
| Consveesfa Enterprise, Inc. | Food/Cosmetics | 02/24/2023 | No Action Indicated (NAI) |
| Coosemans New York, Inc. | Food/Cosmetics | 02/24/2023 | Voluntary Action Indicated (VAI) |
| Creodent Prosthetics, Ltd. | Devices | 06/14/2023 | Voluntary Action Indicated (VAI) |
| Crown Fish, LLC | Food/Cosmetics | 10/24/2023 | Voluntary Action Indicated (VAI) |
| Cyberlogic, Inc. | Devices | 05/24/2023 | No Action Indicated (NAI) |
| D'Arrigo Bros Company Of Ny, Inc. | Food/Cosmetics | 01/25/2023 | No Action Indicated (NAI) |
| Danielle Iacono, OD | Drugs | 07/31/2023 | No Action Indicated (NAI) |
| Delsam Pharma, LLC | Drugs | 03/24/2023 | Official Action Indicated (OAI) |
| E. Armata, Inc. | Food/Cosmetics | 03/21/2023 | Voluntary Action Indicated (VAI) |
| Eemans, LLC | Food/Cosmetics | 06/21/2023 | No Action Indicated (NAI) |
| Eileen's Special Cheesecake, Inc. | Food/Cosmetics | 01/24/2023 | Voluntary Action Indicated (VAI) |
| Eve Sales, Corp. | Food/Cosmetics | 09/19/2023 | No Action Indicated (NAI) |
| Eye Bank For Sight Restoration, Inc. | Biologics | 11/13/2023 | Voluntary Action Indicated (VAI) |
| Forever Cheese, Inc. | Food/Cosmetics | 12/20/2023 | No Action Indicated (NAI) |
| Frito Lay, Inc. | Food/Cosmetics | 06/28/2023 | No Action Indicated (NAI) |
| Fruitco, Corp. | Food/Cosmetics | 01/25/2023 | No Action Indicated (NAI) |
| G21 USA, Inc. | Devices | 07/25/2023 | Voluntary Action Indicated (VAI) |
| Garden Herbs, LLC | Food/Cosmetics | 01/06/2023 | No Action Indicated (NAI) |
| GeneXtend, LLC | Biologics | 09/13/2023 | No Action Indicated (NAI) |
| Genuine Coconut, Inc. | Food/Cosmetics | 09/12/2023 | No Action Indicated (NAI) |
| Gina Group, LLC | Food/Cosmetics | 05/25/2023 | No Action Indicated (NAI) |
| Gourmet Attitude, Inc. | Food/Cosmetics | 06/30/2023 | No Action Indicated (NAI) |
| Gramercy Produce, Inc. | Food/Cosmetics | 02/23/2023 | No Action Indicated (NAI) |
| Gurum Corporation | Food/Cosmetics | 08/15/2023 | Voluntary Action Indicated (VAI) |
| Herbalife International | Food/Cosmetics | 03/21/2023 | No Action Indicated (NAI) |
| Ilya Kister, M.D. | Drugs | 02/06/2023 | No Action Indicated (NAI) |
| J Margiotta Company, LLC | Food/Cosmetics | 01/31/2023 | Voluntary Action Indicated (VAI) |
| J&H Imports Services Corporation | Food/Cosmetics | 08/02/2023 | Voluntary Action Indicated (VAI) |
| Jeffrey W. Moses, M.D. | Devices | 12/14/2023 | No Action Indicated (NAI) |
| Jim W. Cheung, M.D. | Devices | 06/30/2023 | No Action Indicated (NAI) |
| John D. Puskas, M.D. | Devices | 01/17/2023 | No Action Indicated (NAI) |
| Juice Press, LLC | Food/Cosmetics | 03/14/2023 | Voluntary Action Indicated (VAI) |
| Kofinas Fertility Group | Biologics | 07/25/2023 | Voluntary Action Indicated (VAI) |
| Krispy Kreme Doughnuts | Food/Cosmetics | 12/13/2023 | No Action Indicated (NAI) |
| Kyewaa, LLC | Food/Cosmetics | 12/19/2023 | Voluntary Action Indicated (VAI) |
| LA Dulceria, Inc. | Food/Cosmetics | 02/08/2023 | Voluntary Action Indicated (VAI) |
| Laderach Lexington, LLC | Food/Cosmetics | 12/11/2023 | No Action Indicated (NAI) |
| Lindsey Roeker, M.D. | Drugs | 09/12/2023 | No Action Indicated (NAI) |
| MRS Baking Distribution Corporation | Food/Cosmetics | 01/23/2023 | No Action Indicated (NAI) |
| MTV Foods | Food/Cosmetics | 09/08/2023 | Voluntary Action Indicated (VAI) |
| Manhattan Fertility Services, LLC | Biologics | 04/06/2023 | Voluntary Action Indicated (VAI) |
| Marubeni America, Corp. | Food/Cosmetics | 01/26/2023 | No Action Indicated (NAI) |
| Matthew J. Matasar, M.D. | Drugs | 10/26/2023 | No Action Indicated (NAI) |
| Mermaid Sea Products, Inc. | Food/Cosmetics | 02/07/2023 | No Action Indicated (NAI) |
| Milos, Inc. | Food/Cosmetics | 08/11/2023 | No Action Indicated (NAI) |
| Mishaela R. Rubin, M.D. | Drugs | 01/11/2023 | No Action Indicated (NAI) |
| Molino Food Livel, Corp. | Food/Cosmetics | 09/11/2023 | Voluntary Action Indicated (VAI) |
| Montefiore Medical Center Blood Bank | Biologics | 05/18/2023 | Voluntary Action Indicated (VAI) |
| Mount Sinai Health System, Mount Sinai Hospital, Leon and Norma Hess Center for Science and Medicine | Biologics | 10/24/2023 | No Action Indicated (NAI) |
| Mrinal M. Gounder, M.D. | Drugs | 03/03/2023 | Voluntary Action Indicated (VAI) |
| Nadia Ovchinsky, M.D. | Drugs | 03/24/2023 | No Action Indicated (NAI) |
| New Hope Fertility Center | Biologics | 03/03/2023 | Voluntary Action Indicated (VAI) |
| New York Blood Center Enterprises | Biologics | 07/06/2023 | Voluntary Action Indicated (VAI) |
| New York Firefighters Skin Bank New York Presbyterian Hospital | Biologics | 12/19/2023 | No Action Indicated (NAI) |
| New York Presbyterian Hospital Services | Biologics | 08/21/2023 | No Action Indicated (NAI) |
| New York Presbyterian Hospital Weill Cornell Medical College | Biologics | 07/25/2023 | No Action Indicated (NAI) |
| New York Presbyterian Hospital-Columbia University Med. Center | Biologics | 11/28/2023 | Voluntary Action Indicated (VAI) |
| New York University Fertility Center | Biologics | 06/29/2023 | No Action Indicated (NAI) |
| Northeast Lobster NY, Inc. | Food/Cosmetics | 02/23/2023 | No Action Indicated (NAI) |
| Ogilvie Brand, Inc. | Food/Cosmetics | 05/10/2023 | No Action Indicated (NAI) |
| Orogel USA, Inc. | Food/Cosmetics | 01/27/2023 | No Action Indicated (NAI) |
| Peter Charles Klatsky Inc., M.D. | Biologics | 11/06/2023 | No Action Indicated (NAI) |
| Pinnacle Fertility Labs New York | Biologics | 12/14/2023 | Voluntary Action Indicated (VAI) |
| Ports America, Inc. | Food/Cosmetics | 10/10/2023 | Voluntary Action Indicated (VAI) |
| Pria Corporation | Food/Cosmetics | 02/09/2023 | No Action Indicated (NAI) |
| Reyes Produce Corporation | Food/Cosmetics | 03/17/2023 | Voluntary Action Indicated (VAI) |
| Rip Van, Inc. | Food/Cosmetics | 08/22/2023 | No Action Indicated (NAI) |
| Robert A. Lookstein, M.D. | Devices | 03/03/2023 | No Action Indicated (NAI) |
| Rubin Brothers Produce, Corp. | Food/Cosmetics | 03/01/2023 | No Action Indicated (NAI) |
| Russian Shoppe, Inc. | Food/Cosmetics | 12/20/2023 | No Action Indicated (NAI) |
| Sedesco, Inc. | Food/Cosmetics | 02/10/2023 | No Action Indicated (NAI) |
| Sher Fertility Solutions New York | Biologics | 03/20/2023 | No Action Indicated (NAI) |
| Shneiders USA, Inc. | Food/Cosmetics | 01/19/2023 | Voluntary Action Indicated (VAI) |
| Sojitz Corporation of America | Veterinary | 08/11/2023 | Voluntary Action Indicated (VAI) |
| Splendid World, Corp. | Food/Cosmetics | 05/11/2023 | No Action Indicated (NAI) |
| Stemline Therapeutics, Inc. | Drugs | 08/31/2023 | No Action Indicated (NAI) |
| Steven Markowitz, M.D. | Devices | 04/26/2023 | No Action Indicated (NAI) |
| Sunshine Wholesale Groc Company, Inc. | Food/Cosmetics | 12/14/2023 | No Action Indicated (NAI) |
| Superior Tropicals, Inc. | Food/Cosmetics | 05/17/2023 | No Action Indicated (NAI) |
| Sweet Sam's Baking Company, LLC | Food/Cosmetics | 07/20/2023 | Voluntary Action Indicated (VAI) |
| TMRW Life Sciences, Inc. | Devices | 10/24/2023 | Voluntary Action Indicated (VAI) |
| The Rockefeller University Institutional Review Board | Biologics | 08/14/2023 | No Action Indicated (NAI) |
| The Rockefeller University Institutional Review Board | Devices | 08/14/2023 | No Action Indicated (NAI) |
| The Rockefeller University Institutional Review Board | Drugs | 08/14/2023 | No Action Indicated (NAI) |
| United Pickle Products Corporation | Food/Cosmetics | 12/06/2023 | No Action Indicated (NAI) |
| VA NY Harbor Healthcare System IRB | Devices | 05/05/2023 | No Action Indicated (NAI) |
| VA NY Harbor Healthcare System IRB | Drugs | 05/05/2023 | No Action Indicated (NAI) |
| Voss USA, Inc. | Food/Cosmetics | 03/16/2023 | No Action Indicated (NAI) |
| Wako Inflight Service, Inc. | Food/Cosmetics | 03/01/2023 | Voluntary Action Indicated (VAI) |
| Weill Cornell Med College IRB | Biologics | 06/07/2023 | No Action Indicated (NAI) |
| Weill Cornell Med College IRB | Devices | 06/07/2023 | No Action Indicated (NAI) |
| Weill Cornell Med College IRB | Drugs | 06/07/2023 | No Action Indicated (NAI) |
| Wild Edibles, Inc. | Food/Cosmetics | 12/07/2023 | Voluntary Action Indicated (VAI) |
| Wing-On Trading Company, Inc. | Food/Cosmetics | 06/02/2023 | No Action Indicated (NAI) |
| Xtreem Pulse, LLC | Devices | 10/13/2023 | Voluntary Action Indicated (VAI) |
| Zbigniew P. Lorenc, M.D. | Drugs | 06/21/2023 | No Action Indicated (NAI) |
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