There were three companies in cities associated with Middlesex County that received FDA citations as a result of three inspections conducted in the county over the third quarter of 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 50% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- FDA and IRB approval was not obtained for changes to an investigational plan that require prior approval.
- For an investigational study, proper monitoring was not ensured.
- Procedures for corrective and preventive action have not been adequately established.
Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).
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 |
|---|---|---|---|
| Micro Medical Solutions, Inc. | Devices | 07/02/2025 | Sponsors’ general responsibilities |
| Pillar Biosciences, Inc. | Devices | 09/16/2025 | Lack of or inadequate procedures |
| Rejoni, Inc. | Devices | 07/09/2025 | No approval for changes requiring prior approval |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
