Kane County Reporter

There were two companies in cities associated with Will County that received FDA citations as a result of two 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 an increase over the number of companies cited in the previous quarter.

The citations in the county include:

• As a very small importer, you did not obtain written assurance, before importing a food, that your foreign supplier produced the food in compliance with process and procedures that provide the required level of public health protection.
• Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.
• Procedures for quality audits have not been adequately established.

Both 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
Bofas Company Limited	Food and Cosmetics	12/28/2023	Very small importer assurances, supplier
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