There were 14 companies in cities associated with Middlesex County, Massachusetts, that received 14 FDA inspections in the third quarter of 2025, according to the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies inspected in the previous quarter.
Most of the companies inspected at the time operate in the Devices sector. The second most common type of company inspected worked in the Biologics sector.
There were 10 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (71.4%). Three should take voluntary action to correct the organization’s management operations (21.4%). Additionally, one company had to take regulatory and/or administrative actions (7.1%).
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 | Result |
|---|---|---|---|
| Aimmune Therapeutics Manufacturing, LLC | Biologics | 07/25/2025 | No Action Indicated (NAI) |
| Allurion Technologies, Inc. | Devices | 08/14/2025 | No Action Indicated (NAI) |
| Bristol-Myers Squibb Company | Drugs | 07/08/2025 | Voluntary Action Indicated (VAI) |
| California Cryobank, LLC | Biologics | 08/15/2025 | No Action Indicated (NAI) |
| Intrinsic Therapeutics, Inc. | Devices | 09/26/2025 | No Action Indicated (NAI) |
| Ken’s Foods, LLC | Food and Cosmetics | 09/04/2025 | No Action Indicated (NAI) |
| Mama Rosie’s, LLC. | Food and Cosmetics | 09/24/2025 | No Action Indicated (NAI) |
| Micro Medical Solutions, Inc. | Devices | 07/02/2025 | Voluntary Action Indicated (VAI) |
| Navada Imports | Food and Cosmetics | 09/29/2025 | No Action Indicated (NAI) |
| New England Cryogenic Center, Inc. | Biologics | 08/13/2025 | No Action Indicated (NAI) |
| Pillar Biosciences, Inc. | Devices | 09/16/2025 | Voluntary Action Indicated (VAI) |
| Rejoni, Inc. | Devices | 07/09/2025 | Official Action Indicated (OAI) |
| Seres Therapeutics, Inc. | Biologics | 07/29/2025 | No Action Indicated (NAI) |
| Veranova LP | Drugs | 07/31/2025 | No Action Indicated (NAI) |
Information in this story was obtained from the U.S. Food and Drug Administration. The source data can be found here.
