Medina Today

There were two companies in cities associated with Medina County that received FDA citations as a result of two inspections conducted in the county throughout 2023, 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 year.

Of the 10 citations issued, the most common citations include:

• You did not clean utensils and equipment in a manner that protects against contamination.
• You did not identify and evaluate each known or reasonably foreseeable hazard for each type of animal food you manufacture, process, pack or hold in your facility.
• You did not identify and implement preventive controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented.

The companies cited were involved in either Devices, Food and Cosmetics, or Veterinary sectors.

Both companies cited should take voluntary actions to correct their 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.

Company Name	Area of Business	Inspection Date	Issue Cited
Just Mikes Jerky Company, Inc.	Food and Cosmetics	12/07/2023	Sanitation
Just Mikes Jerky Company, Inc.	Food and Cosmetics	12/07/2023	Hazard Analysis
Just Mikes Jerky Company, Inc.	Food and Cosmetics	12/07/2023	Preventive Controls
Just Mikes Jerky Company, Inc.	Veterinary	12/07/2023	Sanitation
Just Mikes Jerky Company, Inc.	Veterinary	12/07/2023	Hazard Analysis
Just Mikes Jerky Company, Inc.	Veterinary	12/07/2023	Preventive Controls
PT Solutions, LLC	Devices	08/10/2023	Documented evaluation
PT Solutions, LLC	Devices	08/10/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
PT Solutions, LLC	Devices	08/10/2023	Lack of or inadequate process validation
PT Solutions, LLC	Devices	08/10/2023	Lack of or inadequate receiving acceptance procedures