South Cuyahoga News

There were 15 companies in cities associated with Cuyahoga County that received FDA citations as a result of 15 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 7.1% increase over the number of companies cited in the previous year.

Of the 62 citations issued, the most common citation was '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 Devices sector. The second most common type of company cited in the time period worked in the the Food and Cosmetics sector.

Of the companies cited, 14 should take voluntary actions to correct their managing operations (93.3%). Additionally, one company had to take regulatory and/or administrative actions (6.7%).

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	Issue Cited
Abraham J. And Phyllis Katz Cord Blood Foundation	Biologics	09/15/2023	Environmental Monitoring System
Abraham J. And Phyllis Katz Cord Blood Foundation	Biologics	09/15/2023	Cleaning System
Abraham J. And Phyllis Katz Cord Blood Foundation	Biologics	09/15/2023	SOPs not followed / documented
Abraham J. And Phyllis Katz Cord Blood Foundation	Biologics	09/15/2023	Maintenance - concurrence
Big Gus Onion Rings, Inc.	Food and Cosmetics	09/07/2023	Hazard analysis - Identification of hazard
Big Gus Onion Rings, Inc.	Food and Cosmetics	09/07/2023	Process preventive controls - Implement
CIT Ortho	Devices	09/05/2023	Design changes - Lack of or Inadequate Procedures
CIT Ortho	Devices	09/05/2023	Lack of or inadequate complaint procedures
Cleveland Bean Sprout, Inc.	Food and Cosmetics	04/10/2023	Training for supervisors
Cleveland Bean Sprout, Inc.	Food and Cosmetics	04/10/2023	Hygienic practices
Cleveland Bean Sprout, Inc.	Food and Cosmetics	04/10/2023	Handling harvested produce
Cleveland Bean Sprout, Inc.	Food and Cosmetics	04/10/2023	Written environmental monitoring plan
Cleveland Bean Sprout, Inc.	Food and Cosmetics	04/10/2023	Written sampling plan for spent irrigation water or sprouts
Cleveland Bean Sprout, Inc.	Food and Cosmetics	04/10/2023	Record - treatment
Cleveland Bean Sprout, Inc.	Food and Cosmetics	04/10/2023	Method - listeria environment - sprouts
Cleveland Medical Devices, Inc.	Devices	07/28/2023	Design Validation - Risk analysis not performed/inadequate
Cleveland Medical Devices, Inc.	Devices	07/28/2023	Purchasing controls, Lack of or inadequate procedures
Cleveland Medical Devices, Inc.	Devices	07/28/2023	Documentation
Cleveland Medical Devices, Inc.	Devices	07/28/2023	Lack of or inadequate complaint procedures
Company-AX Technology, Inc.	Devices	08/02/2023	Supplier oversight
Company-AX Technology, Inc.	Devices	08/02/2023	Supplier notification of changes
Company-AX Technology, Inc.	Devices	08/02/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Company-AX Technology, Inc.	Devices	08/02/2023	Lack of or inadequate process validation
Company-AX Technology, Inc.	Devices	08/02/2023	Lack of or inadequate receiving acceptance procedures
Company-AX Technology, Inc.	Devices	08/02/2023	Nonconforming product, Lack of or inadequate procedures
Company-AX Technology, Inc.	Devices	08/02/2023	Product rework procedures, Lack of or inadequate procedures
Company-AX Technology, Inc.	Devices	08/02/2023	Lack of or inadequate procedures
Company-AX Technology, Inc.	Devices	08/02/2023	Lack of or inadequate complaint procedures
Criterion Tool & Die, Inc.	Devices	02/17/2023	Training - Lack of or inadequate procedures
Criterion Tool & Die, Inc.	Devices	02/17/2023	Purchasing controls, Lack of or inadequate procedures
Criterion Tool & Die, Inc.	Devices	02/17/2023	Equipment control activity documentation
Criterion Tool & Die, Inc.	Devices	02/17/2023	Documentation
Criterion Tool & Die, Inc.	Devices	02/17/2023	Nonconforming product, Lack of or inadequate procedures
Criterion Tool & Die, Inc.	Devices	02/17/2023	Lack of or inadequate procedures
Criterion Tool & Die, Inc.	Devices	02/17/2023	Lack of or inadequate complaint procedures
Economy Produce and Vegetable Company, Inc.	Food and Cosmetics	02/02/2023	Hazard analysis biological, chemical, physical
Euro USA, Inc.	Food and Cosmetics	07/25/2023	HACCP plan implementation
Euro USA, Inc.	Food and Cosmetics	07/25/2023	Critical limits
Euro USA, Inc.	Food and Cosmetics	07/25/2023	Monitoring - adequacy
Euro USA, Inc.	Food and Cosmetics	07/25/2023	Corrective action plan
Euro USA, Inc.	Food and Cosmetics	07/25/2023	Verification procedures - adequacy
Euro USA, Inc.	Food and Cosmetics	07/25/2023	Corrective action per predetermined plan
Euro USA, Inc.	Food and Cosmetics	07/25/2023	Sanitation monitoring
Michael J Rosen, M.D.	Devices	03/01/2023	Investigator non-compliance with agreement/plan/regulations
Roe Dental Lab, Inc.	Devices	10/23/2023	Quality Audit/Reaudit - conducted
Roe Dental Lab, Inc.	Devices	10/23/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Roe Dental Lab, Inc.	Devices	10/23/2023	Lack of or inadequate process validation
Roe Dental Lab, Inc.	Devices	10/23/2023	Documentation
Surgical Theater, Inc.	Devices	03/03/2023	Management representative's reports
Surgical Theater, Inc.	Devices	03/03/2023	Quality Audit/Reaudit - conducted
Surgical Theater, Inc.	Devices	03/03/2023	Design plans - Lack of or inadequate
Surgical Theater, Inc.	Devices	03/03/2023	Design review - documentation
Surgical Theater, Inc.	Devices	03/03/2023	Product rework adverse effects {see also 820.184}
The Orlando Baking Company	Food and Cosmetics	12/08/2023	Personnel
The Orlando Baking Company	Food and Cosmetics	12/08/2023	Sanitation of food-contact surfaces - Frequency
Xellia Pharmaceuticals USA, LLC	Drugs	09/29/2023	Validation lacking for sterile drug products
Xellia Pharmaceuticals USA, LLC	Drugs	09/29/2023	Written record of investigation incomplete
Zuga Medical, Inc.	Devices	06/26/2023	Quality Audit/Reaudit - conducted
Zuga Medical, Inc.	Devices	06/26/2023	Design transfer - Lack of or inadequate procedures
Zuga Medical, Inc.	Devices	06/26/2023	Documentation
Zuga Medical, Inc.	Devices	06/26/2023	Complaints
Zuga Medical, Inc.	Devices	06/26/2023	Evaluation, timeliness, identification