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.
| 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 |



