10 companies in cities within Suffolk County received 10 inspections in Q2 2023

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

By Bean Town Times

Jul 21, 2023

There were 10 companies in cities associated with Suffolk County, Massachusetts, that received 10 FDA inspections in the second quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an 11.1% increase over the number of companies inspected in the previous quarter, when nine companies received nine inspections.

Most of the companies inspected at the time were involved in the Food and Cosmetics sector. The second most common type of company inspected worked in the Drugs sector.

There were six companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (60%). Four should take voluntary action to correct the organization's management operations (40%). Additionally, one company had to take regulatory and/or administrative actions (10%).

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.

Companies Located in Cities Within Suffolk County and Their Inspection Results

Company Name	Area of Business	Inspection Date	Result
4M Fruit Distributors, Inc.	Food and Cosmetics	06/08/2023	No Action Indicated (NAI)
Alexion Pharmaceuticals, Inc.	Drugs	06/30/2023	No Action Indicated (NAI)
Boston Tomato, Inc.	Food and Cosmetics	06/22/2023	Voluntary Action Indicated (VAI)
Brigham and Women's Hospital	Drugs	04/11/2023	No Action Indicated (NAI)
Chinese Spaghetti Factory, Inc.	Food and Cosmetics	06/16/2023	No Action Indicated (NAI)
Denarius Trading Corporation	Food and Cosmetics	04/14/2023	Voluntary Action Indicated (VAI)
GI Dynamics, Inc.	Devices	05/12/2023	No Action Indicated (NAI)
Pacific Seafood Corporation	Food and Cosmetics	06/06/2023	No Action Indicated (NAI)
TEI Biosciences, Inc.	Devices	05/17/2023	Official Action Indicated (OAI)
TEI Biosciences, Inc.	Devices	05/17/2023	Voluntary Action Indicated (VAI)
Vertex Pharmaceuticals Incorporated	Drugs	05/04/2023	Voluntary Action Indicated (VAI)