There were 15 companies in cities associated with Bergen County that received FDA citations as a result of 16 inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 40% decrease from the number of companies cited in the previous year.
Of the 45 citations issued, the most common citations include:
- You did not develop an FSVP.
- You did not have a written hazard analysis.
- You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier’s performance and the risk posed by a food.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company operated in the Devices sector.
All of the companies cited should take voluntary actions to correct their managing operations.
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Deborah A. Goss, M.D. | Devices | 03/17/2025 | Investigator non-compliance with agreement/plan/regulations |
| Deborah A. Goss, M.D. | Devices | 03/17/2025 | Investigator’s subject records inadequate |
| Deborah A. Goss, M.D. | Devices | 03/17/2025 | Record retention inadequate |
| Deborah A. Goss, M.D. | Devices | 03/17/2025 | Investigator report of unanticipated adverse effects |
| Frutikas Distributing, LLC | Food and Cosmetics | 02/26/2025 | Supplier verification assurance |
| Frutikas Distributing, LLC | Food and Cosmetics | 02/26/2025 | Verification activity assurance |
| Grant Industries, Inc. | Drugs | 06/16/2025 | Procedures not in writing, fully followed |
| Grant Industries, Inc. | Drugs | 06/16/2025 | Training–operations, GMPs, written procedures |
| Grant Industries, Inc. | Drugs | 06/16/2025 | Computer control of master formula records |
| Grant Industries, Inc. | Drugs | 06/16/2025 | Component identity verification |
| Grant Industries, Inc. | Drugs | 06/16/2025 | Absence of Written Procedures |
| Grant Industries, Inc. | Drugs | 06/16/2025 | Valid stability test methods |
| Grant Industries, Inc. | Drugs | 06/16/2025 | Testing and standardization of standards et. al. |
| Green Village USA, Inc. | Food and Cosmetics | 10/22/2025 | Very small importer assurances, supplier |
| Jorday Foods International, LLC | Food and Cosmetics | 03/21/2025 | Hazard analysis written |
| Jorday Foods International, LLC | Food and Cosmetics | 03/21/2025 | Document review entity’s hazard analysis |
| Jorday Foods International, LLC | Food and Cosmetics | 03/21/2025 | Evaluation – performance, risk |
| Jorday Foods International, LLC | Food and Cosmetics | 03/21/2025 | Supplier approval – document |
| Jorday Foods International, LLC | Food and Cosmetics | 03/21/2025 | Supplier verification – establish written procedures |
| Jorday Foods International, LLC | Food and Cosmetics | 03/21/2025 | Verification activity frequency |
| Jorday Foods International, LLC | Food and Cosmetics | 10/30/2025 | Hazard analysis written |
| Jorday Foods International, LLC | Food and Cosmetics | 10/30/2025 | Evaluation – performance, risk |
| Jorday Foods International, LLC | Food and Cosmetics | 10/30/2025 | Supplier approval – document |
| Jorday Foods International, LLC | Food and Cosmetics | 10/30/2025 | Verification activity frequency |
| Mkj Brands, LLC. | Devices | 01/08/2025 | Purchasing controls, Lack of or inadequate procedures |
| Mkj Brands, LLC. | Devices | 01/08/2025 | Lack of or inadequate procedures – Acceptance activities |
| Natural Nut & Spice, Inc. | Food and Cosmetics | 10/29/2025 | Develop FSVP |
| Natural Nut & Spice, Inc. | Food and Cosmetics | 10/29/2025 | Verification activity before import, periodically |
| Nimesh P. Nagarsheth, M.D. | Drugs | 03/31/2025 | Safety Reports – Serious Events |
| Off The Hook Seafood, LLC | Food and Cosmetics | 04/18/2025 | Sanitation monitoring |
| Petnet Solutions, Inc. | Drugs | 09/19/2025 | Determination need for investigation |
| Petnet Solutions, Inc. | Drugs | 09/19/2025 | Orderly handling, prevention of mix-ups, prevention of contamination |
| RD Foods Americas, Inc. | Food and Cosmetics | 09/04/2025 | Importer verification |
| Titan Implants, Inc. | Devices | 02/20/2025 | Evaluation of suppliers, contractors, etc., requirements |
| Titan Implants, Inc. | Devices | 02/20/2025 | Documentation |
| Topcon Medical Systems, Inc. | Devices | 03/14/2025 | Report of Death or Serious Injury |
| Topcon Medical Systems, Inc. | Devices | 03/14/2025 | Management review – Lack of or inadequate procedures |
| Topcon Medical Systems, Inc. | Devices | 03/14/2025 | Quality audits – auditor independence |
| Topcon Medical Systems, Inc. | Devices | 03/14/2025 | Design Validation – Risk analysis not performed/inadequate |
| Topcon Medical Systems, Inc. | Devices | 03/14/2025 | Design validation- Lack of or inadequate procedures |
| Topcon Medical Systems, Inc. | Devices | 03/14/2025 | Lack of or inadequate procedures |
| Topcon Medical Systems, Inc. | Devices | 03/14/2025 | Complaints |
| Triangle Manufacturing Company, Inc. | Devices | 06/12/2025 | Training – Lack of or inadequate procedures |
| Triangle Manufacturing Company, Inc. | Devices | 06/12/2025 | Lack of or inadequate process validation |
| Yara Test Company | Food and Cosmetics | 03/26/2025 | Develop FSVP |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
