South Cuyahoga News

There were 12 companies in cities associated with Cuyahoga County, Ohio, that received 12 FDA inspections in the third quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 7.7% decrease from the number of companies inspected in the previous quarter, when 13 companies received 13 inspections.

Most of the companies inspected at the time were involved in the Biologics and Devices sectors. Both the Drugs and Food and Cosmetics sectors sectors tied for second most common type.

There were seven companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (58.3%). Five should take voluntary action to correct their management operations (41.7%).

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	Result
Abraham J. And Phyllis Katz Cord Blood Foundation	Biologics	09/15/2023	Voluntary Action Indicated (VAI)
Bay Corporation	Devices	09/26/2023	No Action Indicated (NAI)
Big Gus Onion Rings, Inc.	Food and Cosmetics	09/07/2023	Voluntary Action Indicated (VAI)
CIT Ortho	Devices	09/05/2023	Voluntary Action Indicated (VAI)
CMC Pharmaceuticals, Inc.	Drugs	09/27/2023	No Action Indicated (NAI)
Cleveland Clinic Fertility Center	Biologics	09/19/2023	No Action Indicated (NAI)
Cleveland Medical Devices, Inc.	Devices	07/28/2023	Voluntary Action Indicated (VAI)
Company-AX Technology, Inc.	Devices	08/02/2023	Voluntary Action Indicated (VAI)
Heinen's, Inc.	Food and Cosmetics	07/26/2023	No Action Indicated (NAI)
The American National Red Cross	Biologics	08/18/2023	No Action Indicated (NAI)
The Cleveland Clinic Foundation	Biologics	09/21/2023	No Action Indicated (NAI)
VA Northeast Ohio Healthcare System IRB	Biologics	07/24/2023	No Action Indicated (NAI)
VA Northeast Ohio Healthcare System IRB	Devices	07/24/2023	No Action Indicated (NAI)
VA Northeast Ohio Healthcare System IRB	Drugs	07/24/2023	No Action Indicated (NAI)