Lake County Gazette

There were seven companies in cities associated with Lake County that received FDA citations as a result of seven inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 36.4% decrease from the number of companies cited in the previous year.

Of the 22 citations issued, the most common citations include:

• An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
• Procedures for corrective and preventive action have not been adequately established.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked 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.

According to its website, 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.

Company Name	Area of Business	Inspection Date	Issue Cited
Arxium, Inc.	Devices	04/01/2024	Lack of or inadequate procedures
Arxium, Inc.	Devices	04/01/2024	Lack of or inadequate complaint procedures
BioLife Plasma Services L. P.	Biologics	08/22/2024	Individual Report of Malfunction
GE Healthcare, Inc.	Drugs	03/08/2024	Ensuring compliance with plan and protocol
Miracapo Pizza Company, LLC	Food and Cosmetics	07/19/2024	Sanitary operations - Plant maintenance
Miracapo Pizza Company, LLC	Food and Cosmetics	07/19/2024	Sanitary operations - Plant sanitation
North American Herb and Spice Company, LLC, Ltd.	Food and Cosmetics	05/13/2024	Specifications-component purity, strength, composition
North American Herb and Spice Company, LLC, Ltd.	Food and Cosmetics	05/13/2024	Appropriate tests, examinations; certificate of analysis
North American Herb and Spice Company, LLC, Ltd.	Food and Cosmetics	05/13/2024	Specifications met - verify; finished batch
North American Herb and Spice Company, LLC, Ltd.	Food and Cosmetics	05/13/2024	Material review, disposition, follow-up; investigation
North American Herb and Spice Company, LLC, Ltd.	Food and Cosmetics	05/13/2024	Hazard analysis - Conducted
North American Herb and Spice Company, LLC, Ltd.	Food and Cosmetics	05/13/2024	Supply-chain program - Supplier approval
Quality Catering for Kids, Inc.	Food and Cosmetics	01/16/2024	Personnel
Quality Catering for Kids, Inc.	Food and Cosmetics	01/16/2024	Plant construction and design
Quality Catering for Kids, Inc.	Food and Cosmetics	01/16/2024	Storage and Distribution
Stericycle, Inc.	Devices	02/12/2024	Individual Report of Malfunction
Stericycle, Inc.	Devices	02/12/2024	Design history file
Stericycle, Inc.	Devices	02/12/2024	Lack of or inadequate procedures - Acceptance activities
Stericycle, Inc.	Devices	02/12/2024	Lack of or inadequate procedures
Stericycle, Inc.	Devices	02/12/2024	Lack of or inadequate DHR procedures
Stericycle, Inc.	Devices	02/12/2024	Lack of or inadequate complaint procedures
Stericycle, Inc.	Devices	02/12/2024	Sampling methods - Lack of or inadequate procedures