South Middlesex Times

There were two companies in cities associated with Middlesex County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• Written procedures have not been developed for the surveillance and reporting to FDA of post marketing adverse drug experiences.
• A postmarketing 15-day Alert report based upon scientific literature was not accompanied by a copy of the published article.
• You did not develop an FSVP.

Both companies cited were involved in either Drugs or Food and Cosmetics sectors.

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.

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
Ambrosia Parade Restaurant, LLC	Food and Cosmetics	02/02/2024	Develop FSVP
Ambrosia Parade Restaurant, LLC	Food and Cosmetics	02/02/2024	Document review entity's hazard analysis
Ambrosia Parade Restaurant, LLC	Food and Cosmetics	02/02/2024	Evaluation - performance, risk
Ambrosia Parade Restaurant, LLC	Food and Cosmetics	02/02/2024	Supplier approval - document
Ambrosia Parade Restaurant, LLC	Food and Cosmetics	02/02/2024	Verification activity - appropriate
Tris Pharma, Inc.	Drugs	03/08/2024	Failure to develop written procedures
Tris Pharma, Inc.	Drugs	03/08/2024	Failure to submit scientific article