FDA: 3 companies in cities within DuPage County received 9 citations in March

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

By DuPage Policy Journal

Apr 1, 2024

There were three companies in cities associated with DuPage 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 200% increase over the number of companies cited in the previous month.

The citations in the county include:

You did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
MDR event files do not contain or reference all adverse event information in the possession of the reporting entity, including documentation of the deliberations and decision making process used to determine if an event was or was not reportable.

All of the companies cited were involved in either Biologics, Devices, or Food and Cosmetics sectors.

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 DuPage County Cities and the citations they received in March

Company Name	Area of Business	Inspection Date	Issue Cited
Midwest Sperm Bank, LLC	Biologics	03/20/2024	Testing, screening, donor eligibility procedures
Midwest Sperm Bank, LLC	Biologics	03/20/2024	Determination based on screening and testing
SpineCraft, LLC.	Devices	03/22/2024	Adverse events--all info not in file
SpineCraft, LLC.	Devices	03/22/2024	Complaints
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