North Boston News

There were 10 companies in cities associated with Essex County that received FDA citations as a result of 10 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 23.1% decrease from the number of companies cited in the previous year.

Of the 26 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.

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

Of the companies cited, eight should take voluntary actions to correct their managing operations (80%). Additionally, two companies had to take regulatory and/or administrative actions (20%).

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
Abiomed, Inc.	Devices	04/13/2023	Report of Death or Serious Injury
Abiomed, Inc.	Devices	04/13/2023	Individual Report of Malfunction
Abiomed, Inc.	Devices	04/13/2023	Report of risk to health
Abiomed, Inc.	Devices	04/13/2023	Lack of or inadequate procedures
Abiomed, Inc.	Devices	04/13/2023	Lack of or inadequate complaint procedures
Abiomed, Inc.	Devices	04/13/2023	Investigation of device failures
BC Gourmet USA, Inc.	Food and Cosmetics	12/01/2023	Sanitation preventive controls - Implement
Demakes Enterprises, Inc.	Food and Cosmetics	09/06/2023	HACCP plan - corrective action plan not included
Demakes Enterprises, Inc.	Food and Cosmetics	09/06/2023	HACCP plan - verify procedures / frequency - none listed
Fresenius Kabi USA, LLC	Devices	09/07/2023	Individual Report of Malfunction
Fresenius Kabi USA, LLC	Devices	09/07/2023	Report of risk to health
Fresenius Kabi USA, LLC	Devices	09/07/2023	Design Validation - Risk analysis not performed/inadequate
Fresenius Kabi USA, LLC	Devices	09/07/2023	Design changes - Lack of or Inadequate Procedures
Fresenius Kabi USA, LLC	Devices	09/07/2023	Lack of or inadequate procedures
Hamilton Thorne, Inc.	Devices	11/09/2023	Lack of or inadequate procedures
Intershell International Corporation	Food and Cosmetics	12/07/2023	HACCP plan implementation
Intershell International Corporation	Food and Cosmetics	12/07/2023	Critical limits
Pier 7, Inc.	Food and Cosmetics	04/11/2023	HACCP plan location
Pier 7, Inc.	Food and Cosmetics	04/11/2023	No HACCP plan
Pier 7, Inc.	Food and Cosmetics	04/11/2023	Sanitation Records
Rich Products Corporation	Food and Cosmetics	11/30/2023	Personnel
Shawsheen Rubber Company, Inc.	Drugs	03/13/2023	Component identity verification
Shawsheen Rubber Company, Inc.	Drugs	03/13/2023	Reports of Analysis (Components)
Shawsheen Rubber Company, Inc.	Drugs	03/13/2023	Testing and release for distribution
Shawsheen Rubber Company, Inc.	Drugs	03/13/2023	Lack of or inadequate process validation
The Butchery	Food and Cosmetics	08/14/2023	Sanitation Records