FDA: 6 companies in cities within Will County received 11 citations in 2023

Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

By DuPage Policy Journal

Oct 28, 2024

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

This is a 14.3% decrease from the number of companies cited in the previous year.

Of the 11 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 Devices sector. The second most common type of company cited in the time period worked in the 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.

Companies Located Within Will County Cities and the Citations They Received in 2023

Company Name	Area of Business	Inspection Date	Issue Cited
Bofas Company Limited	Food and Cosmetics	12/28/2023	Very small importer assurances, supplier
ISOVAC Products, LLC	Devices	05/11/2023	Purchasing controls, Lack of or inadequate procedures
ISOVAC Products, LLC	Devices	05/11/2023	Lack of or inadequate In-process acceptance procedures
ISOVAC Products, LLC	Devices	05/11/2023	Documentation
Inventus Power, Inc.	Devices	03/28/2023	Lack of or inadequate procedures
Inventus Power, Inc.	Devices	03/28/2023	Documentation
Randy Morris School, M.D.	Biologics	06/14/2023	Risk factors, clinical evidence
Sands Impex, Inc.	Food and Cosmetics	06/26/2023	Develop FSVP
Stericycle, Inc.	Devices	12/21/2023	Management review - defined interval, sufficient frequency
Stericycle, Inc.	Devices	12/21/2023	Quality audits - Lack of or inadequate procedures
Stericycle, Inc.	Devices	12/21/2023	Lack of or inadequate procedures