North Cincy News

There were 13 companies in cities associated with Hamilton County that received FDA citations as a result of 13 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an 8.3% increase over the number of companies cited in the previous year.

Of the 33 citations issued, the most common citations include:

• Procedures for corrective and preventive action have not been adequately established.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
• Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Biologics sector.

Of the companies cited, 12 should take voluntary actions to correct their managing operations (92.3%). Additionally, one company had to take regulatory and/or administrative actions (7.7%).

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
Baxters North America, Inc.	Food and Cosmetics	07/26/2023	Allergen preventive controls - Implement
Baxters North America, Inc.	Food and Cosmetics	07/26/2023	Sanitation preventive controls - Implement
Baxters North America, Inc.	Food and Cosmetics	07/26/2023	Allergen preventive controls - Implementation records
Cincinnati Childrens Hospital Medical Center	Biologics	07/12/2023	Risk factors, clinical evidence
Cincinnati Childrens Hospital Medical Center	Biologics	07/12/2023	Kits not FDA approved, specifically labeled
Dynavision Global Holdings, LLC	Devices	08/31/2023	Design verification - documentation
Dynavision Global Holdings, LLC	Devices	08/31/2023	Purchasing controls, Lack of or inadequate procedures
Dynavision Global Holdings, LLC	Devices	08/31/2023	Nonconforming product, Lack of or inadequate procedures
Dynavision Global Holdings, LLC	Devices	08/31/2023	Lack of or inadequate procedures
Dynavision Global Holdings, LLC	Devices	08/31/2023	Lack of or inadequate complaint procedures
Enson Group, Inc.	Food and Cosmetics	04/24/2023	Develop FSVP
FKC, LLC	Food and Cosmetics	04/07/2023	Manufacturing, processing, packing, holding - Controls
FKC, LLC	Food and Cosmetics	04/07/2023	Food safety hazards
Fries Brothers, Inc.	Food and Cosmetics	05/09/2023	Develop FSVP
Fries Brothers, Inc.	Food and Cosmetics	05/09/2023	Hazard analysis written
Fries Brothers, Inc.	Food and Cosmetics	05/09/2023	Supplier approval - document
Fries Brothers, Inc.	Food and Cosmetics	05/09/2023	Approved supplier procedures - importer established
Fries Brothers, Inc.	Food and Cosmetics	05/09/2023	Supplier verification - establish written procedures
Fries Brothers, Inc.	Food and Cosmetics	05/09/2023	Verification activity assurance
Garys Cheesecakes & Fine Desserts	Food and Cosmetics	02/15/2023	Sanitary operations - Plant maintenance
Garys Cheesecakes & Fine Desserts	Food and Cosmetics	02/15/2023	Pest control
Institute for Reproductive Health	Biologics	08/30/2023	Risk factors, clinical evidence
Kaiser Foods, Inc.	Food and Cosmetics	07/21/2023	Scheduled process
Kaiser Foods, Inc.	Food and Cosmetics	07/21/2023	Maintenance of processing and production records
Love Force, LLC	Food and Cosmetics	06/09/2023	Personnel
Love Force, LLC	Food and Cosmetics	06/09/2023	Sanitary operations - Plant sanitation
Love Force, LLC	Food and Cosmetics	06/09/2023	Equipment and utensils - Design and maintenance
Richard B. Powell, M.D.	Biologics	05/24/2023	FD-1572, protocol compliance
Richard B. Powell, M.D.	Biologics	05/24/2023	Case history records- inadequate or inadequate
Surgical Appliance Industries, Inc.	Devices	10/18/2023	Nonconforming product, Lack of or inadequate procedures
Surgical Appliance Industries, Inc.	Devices	10/18/2023	Lack of or inadequate procedures
Surgical Appliance Industries, Inc.	Devices	10/18/2023	Lack of or inadequate complaint procedures
Wilbur-Ellis Nutrition	Veterinary	08/16/2023	Establishment and Implementation of Monitoring Preventive Controls