North Boston News

There were 40 companies in cities associated with Suffolk County, Massachusetts, that received 41 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 4.8% decrease from the number of companies inspected in the previous year, when 42 companies were inspected through 43 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 Drugs and Devices sectors.

There were 24 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (60%). 16 should take voluntary action to correct the organization's management operations (40%). Additionally, one company had to take regulatory and/or administrative actions (2.5%).

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
4M Fruit Distributors, Inc.	Food/Cosmetics	06/08/2023	No Action Indicated (NAI)
Air Culinaire Worldwide, LLC	Food/Cosmetics	02/06/2023	Voluntary Action Indicated (VAI)
Alexion Pharmaceuticals, Inc.	Drugs	06/30/2023	No Action Indicated (NAI)
Alexion Pharmaceuticals, Inc.	Drugs	09/14/2023	No Action Indicated (NAI)
Atlantic Animal Health, Inc.	Veterinary	03/16/2023	Voluntary Action Indicated (VAI)
Aveo Pharmaceuticals, Inc.	Drugs	09/15/2023	No Action Indicated (NAI)
Barbara L. Smith, PhD., M.D.	Devices	08/04/2023	No Action Indicated (NAI)
Beth Israel Deaconess Medical Center	Biologics	09/11/2023	No Action Indicated (NAI)
Boston Medical Center Corporation	Biologics	09/12/2023	No Action Indicated (NAI)
Boston Tomato, Inc.	Food/Cosmetics	06/22/2023	Voluntary Action Indicated (VAI)
Brigham and Women's Hospital	Drugs	04/11/2023	No Action Indicated (NAI)
Cape Cod Shellfish & Seafood Company, Inc.	Food/Cosmetics	01/26/2023	No Action Indicated (NAI)
Chinese Scallion Pie, Inc.	Food/Cosmetics	12/28/2023	Voluntary Action Indicated (VAI)
Chinese Spaghetti Factory, Inc.	Food/Cosmetics	06/16/2023	No Action Indicated (NAI)
Christopher J. Hartnick, M.D.	Devices	10/27/2023	No Action Indicated (NAI)
Community Suffolk, Inc.	Food/Cosmetics	07/17/2023	No Action Indicated (NAI)
Denarius Trading Corporation	Food/Cosmetics	04/14/2023	Voluntary Action Indicated (VAI)
Fleet Street Fruit Market, Inc.	Food/Cosmetics	07/13/2023	No Action Indicated (NAI)
GHE Group, Company	Food/Cosmetics	01/17/2023	Voluntary Action Indicated (VAI)
GI Dynamics, Inc.	Devices	05/12/2023	No Action Indicated (NAI)
Gelesis, Inc.	Devices	01/25/2023	Voluntary Action Indicated (VAI)
John Mantia & Sons Company, Inc.	Food/Cosmetics	01/31/2023	Voluntary Action Indicated (VAI)
Lun Fat Produce, Inc.	Food/Cosmetics	07/20/2023	Voluntary Action Indicated (VAI)
MGH Fertility Center, Vincent Reproductive Medicine & IVF	Biologics	09/21/2023	No Action Indicated (NAI)
Mutual Produce, Corp.	Food/Cosmetics	07/11/2023	No Action Indicated (NAI)
Navneet K. Virk Hundal, M.D.	Drugs	11/03/2023	No Action Indicated (NAI)
New England Banana Company, Inc.	Food/Cosmetics	08/28/2023	No Action Indicated (NAI)
PHASE-N Corporation	Devices	02/09/2023	Voluntary Action Indicated (VAI)
Pacific Seafood Corporation	Food/Cosmetics	06/06/2023	No Action Indicated (NAI)
Peter Condakes Company, Inc.	Food/Cosmetics	08/30/2023	No Action Indicated (NAI)
Priscilla A. Merriam, M.D.	Drugs	02/24/2023	No Action Indicated (NAI)
RRG Holton, LLC	Food/Cosmetics	08/18/2023	Voluntary Action Indicated (VAI)
S. Strock & Company, Inc.	Food/Cosmetics	07/12/2023	No Action Indicated (NAI)
Servier US, Inc.	Drugs	08/04/2023	No Action Indicated (NAI)
Seven Hills Farmstead, LLC	Food/Cosmetics	07/20/2023	Voluntary Action Indicated (VAI)
State Garden, Inc.	Food/Cosmetics	10/05/2023	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)
The Alphas Company, Inc.	Food/Cosmetics	01/24/2023	Voluntary Action Indicated (VAI)
Tufts Health Sciences IRB	Biologics	12/07/2023	No Action Indicated (NAI)
Tufts Health Sciences IRB	Devices	12/07/2023	No Action Indicated (NAI)
Tufts Health Sciences IRB	Drugs	12/07/2023	No Action Indicated (NAI)
Vertex Pharmaceuticals Incorporated	Drugs	05/04/2023	Voluntary Action Indicated (VAI)
Whele, LLC	Devices	07/18/2023	Voluntary Action Indicated (VAI)