How many companies in cities across Lake County received FDA citations in February?

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

By Lake County Gazette

Mar 1, 2024

There was one company in a city associated with Lake County that received FDA citations as a result of one inspection conducted in the county in February, 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 month.

The citations in the county 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.
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Procedures for acceptance activities have not been adequately established.

The company cited was involved in the Devices sector.

The company cited should take a voluntary action to correct its 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 Lake County Cities and the citations they received in February

Company Name	Area of Business	Inspection Date	Issue Cited
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