South Middlesex Times

There was one company in a city associated with Middlesex County that received FDA citations as a result of one inspection conducted in the county in March, according to reports from the U.S. Food and Drug Administration (FDA).

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

The citations in the county were 'Written procedures have not been developed for the surveillance and reporting to FDA of post marketing adverse drug experiences' and 'A postmarketing 15-day Alert report based upon scientific literature was not accompanied by a copy of the published article'.

The company cited should take a voluntary action to correct its 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.

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, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
Tris Pharma, Inc.	Drugs	03/08/2024	Failure to develop written procedures
Tris Pharma, Inc.	Drugs	03/08/2024	Failure to submit scientific article