North Boston News

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

This is a 33.3% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• Procedures for corrective and preventive action have not been adequately established.
• You did not implement the monitoring procedures listed in your HACCP plan.
• Your HACCP plan lists a critical limit that does not ensure control of one or more hazards.

All of the companies cited should take voluntary actions to correct their managing operations.

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
BC Gourmet USA, Inc.	Food and Cosmetics	12/01/2023	Sanitation preventive controls - Implement
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
Rich Products Corporation	Food and Cosmetics	11/30/2023	Personnel