North Boston News

There were 21 companies in cities associated with Essex County, Massachusetts, that received 22 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 27.6% decrease from the number of companies inspected in the previous year, when 29 companies were inspected through 31 inspections.

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

There were 10 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (47.6%). Nine should take voluntary action to correct the organization's management operations (42.9%). Additionally, two companies had to take regulatory and/or administrative actions (9.5%).

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
Abiomed, Inc.	Devices	04/13/2023	Official Action Indicated (OAI)
BC Gourmet USA, Inc.	Food/Cosmetics	12/01/2023	Voluntary Action Indicated (VAI)
Bakaliko Unique Greek Imports, LLC	Food/Cosmetics	03/30/2023	No Action Indicated (NAI)
Demakes Enterprises, Inc.	Food/Cosmetics	09/06/2023	Voluntary Action Indicated (VAI)
Fresenius Kabi USA, LLC	Devices	09/07/2023	Official Action Indicated (OAI)
Half Moon Mods, LLC	Tobacco	04/17/2023	No Action Indicated (NAI)
Hamilton Thorne, Inc.	Devices	11/09/2023	Voluntary Action Indicated (VAI)
Intershell International Corporation	Food/Cosmetics	12/07/2023	Voluntary Action Indicated (VAI)
Ipswich Shellfish Company, Inc.	Food/Cosmetics	06/01/2023	No Action Indicated (NAI)
Mondelez Global	Food/Cosmetics	02/16/2023	No Action Indicated (NAI)
Ora, Inc.	Drugs	06/28/2023	No Action Indicated (NAI)
Pier 7, Inc.	Food/Cosmetics	04/11/2023	Voluntary Action Indicated (VAI)
Pigeon Cove Ferments	Food/Cosmetics	05/08/2023	No Action Indicated (NAI)
Prova, Inc.	Food/Cosmetics	09/21/2023	No Action Indicated (NAI)
Rich Products Corporation	Food/Cosmetics	11/30/2023	Voluntary Action Indicated (VAI)
Salame Transport & Distribution, LLC	Food/Cosmetics	09/21/2023	No Action Indicated (NAI)
Seacrest Foods International, Inc.	Food/Cosmetics	06/20/2023	No Action Indicated (NAI)
Shawsheen Rubber Company, Inc.	Drugs	03/13/2023	Voluntary Action Indicated (VAI)
The Butchery	Food/Cosmetics	08/14/2023	Voluntary Action Indicated (VAI)
Traditional Breads, Inc.	Food/Cosmetics	02/09/2023	No Action Indicated (NAI)
Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC	Biologics	09/19/2023	Voluntary Action Indicated (VAI)
Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC	Drugs	10/13/2023	No Action Indicated (NAI)