How many FDA citations were issued in cities within Somerset County in Q3

There were two companies in cities associated with Somerset County that received FDA citations as a result of two inspections conducted in the county over the third quarter of 2025, according to the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous quarter.

The citations in the county include:

• An application holder did not identify and address non-compliant certified healthcare providers (HCPs), as required by your approved REMS Element to Assure Safe Use (ETASU) A.
• An application holder did not maintain the drug distribution and dispensing records to ensure restricted distribution, as required by your approved REMS Implementation System.
• 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.

Both 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.

Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.