How many companies in cities across Cook County received FDA citations in January?

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

By North Cook News

Feb 1, 2024

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

This is unchanged from the number of companies cited in the previous month.

The citations in the county include:

You did not ensure that your electronic mail address and the unique facility identifier recognized as acceptable by FDA were provided electronically when filing entry with the U.S. Customs and Border Protection.
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 design change have not been adequately established.

Of the companies cited, two should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (50%).

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 Cook County Cities and the citations they received in January

Company Name	Area of Business	Inspection Date	Issue Cited
MEDLINE INDUSTRIES, LP - Northfield	Devices	01/22/2024	Individual Report of Malfunction
MEDLINE INDUSTRIES, LP - Northfield	Devices	01/22/2024	Design changes - Lack of or Inadequate Procedures
MEDLINE INDUSTRIES, LP - Northfield	Devices	01/22/2024	Purchasing controls, Lack of or inadequate procedures
MEDLINE INDUSTRIES, LP - Northfield	Devices	01/22/2024	Lack of or inadequate procedures
MEDLINE INDUSTRIES, LP - Northfield	Devices	01/22/2024	Lack of or inadequate complaint procedures
Mars Foods US	Food and Cosmetics	01/11/2024	Identification - entry