Kane County Reporter

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

This is a 50% decrease from the number of companies cited in the previous year.

The citations in the county include:

• 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.
• Procedures for corrective and preventive action have not been adequately established.

Most of the companies cited were involved in the Devices 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
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Supplier approval - document
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Approved supplier procedures - importer established
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Supplier verification - establish written procedures
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Verification activity frequency
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Verification activity assurance
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Verification activity before import, periodically
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Record - translate to English
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
Tricor Systems	Devices	03/08/2023	Lack of Written MDR Procedures
Tricor Systems	Devices	03/08/2023	Training - Lack of or inadequate procedures
Tricor Systems	Devices	03/08/2023	Supplier oversight
Tricor Systems	Devices	03/08/2023	Servicing - Lack of or inadequate procedures