North Cook News

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

This is a 25% decrease from the number of companies cited in the previous month.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size to facilitate cleaning, maintenance, and proper operations.
• Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Most of the companies cited were involved in the Food and Cosmetics sector.

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
A. B. Company, Inc.	Food and Cosmetics	03/22/2024	Develop FSVP
RNA Coporation	Drugs	03/08/2024	Procedures not in writing, fully followed
RNA Coporation	Drugs	03/08/2024	Buildings of Suitable Size, Construction, Location
RNA Coporation	Drugs	03/08/2024	Computer control of master formula records
RNA Coporation	Drugs	03/08/2024	Procedures for non-sterile drug products
VHRK Food, Inc.	Food and Cosmetics	03/27/2024	Hazard analysis biological, chemical, physical
VHRK Food, Inc.	Food and Cosmetics	03/27/2024	Document review entity's hazard analysis
VHRK Food, Inc.	Food and Cosmetics	03/27/2024	Approved supplier procedures - importer established
VHRK Food, Inc.	Food and Cosmetics	03/27/2024	Supplier verification - establish written procedures
VHRK Food, Inc.	Food and Cosmetics	03/27/2024	Verification activity assurance