There were four companies in cities associated with Bronx County that received FDA citations as a result of four inspections conducted in the county over the second quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 20% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier’s performance and the risk posed by a food or based on a review and assessment of another entity’s evaluation of a foreign supplier’s performance and the risk posed by a food.
- You did not determine and document the frequency of conducting the verification activities to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.
- You did not conduct and document or obtain documentation of one or more supplier verification activities before importing the food into the United States.
Most of the companies cited were involved in the Food and Cosmetics 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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Billybey Marina Services, LLC | Food and Cosmetics | 05/08/2025 | Prevention of contamination |
| Gustiamo, Inc. | Food and Cosmetics | 05/29/2025 | Supplier approval – document |
| Gustiamo, Inc. | Food and Cosmetics | 05/29/2025 | Verification activity frequency |
| Gustiamo, Inc. | Food and Cosmetics | 05/29/2025 | Verification activity before import, periodically |
| New Kam Manager, LLC | Food and Cosmetics | 05/01/2025 | Develop FSVP |
| Renalytix AI, Inc. | Devices | 04/11/2025 | Lack of Written MDR Procedures |
| Renalytix AI, Inc. | Devices | 04/11/2025 | Lack of or inadequate complaint procedures |









