North Boston News

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

This is a 14.3% decrease from the number of companies inspected in the previous quarter, when seven companies received seven inspections.

Most of the companies inspected at the time were involved in the Food and Cosmetics sector. Both the Biologics and Devices sectors sectors tied for second most common type.

There were two companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. Three should take voluntary action to correct the organization's management operations. Additionally, one company had to take regulatory and/or administrative actions.

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	Result
Demakes Enterprises, Inc.	Food and Cosmetics	09/06/2023	Voluntary Action Indicated (VAI)
Fresenius Kabi USA, LLC	Devices	09/07/2023	Official Action Indicated (OAI)
Prova, Inc.	Food and Cosmetics	09/21/2023	No Action Indicated (NAI)
Salame Transport & Distribution, LLC	Food and Cosmetics	09/21/2023	No Action Indicated (NAI)
The Butchery	Food and Cosmetics	08/14/2023	Voluntary Action Indicated (VAI)
Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC	Biologics	09/19/2023	Voluntary Action Indicated (VAI)