There were three companies in a city associated with New York County that received FDA citations as a result of three 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 25% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Failure to maintain and operate servicing area piping systems and hydrants in such a manner as to prevent contamination of drinking and culinary water.
- Written MDR procedures have not been implemented.
- Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
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 |
| 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 |
