EC Ohio News

There were two companies in cities associated with Holmes 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 unchanged from the number of companies cited in the previous year.

The citations in the county include:

• Documents that were not approved were observed at a location where they could be used.
• Equipment maintenance activities have not been documented.
• Procedures for corrective and preventive action have not been adequately established.

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
Bunker Hill Cheese Company, Inc.	Food and Cosmetics	01/31/2023	Process preventive controls - Identify (Written)
Bunker Hill Cheese Company, Inc.	Food and Cosmetics	01/31/2023	Sanitation preventive controls - Appropriate (Adequate)
Bunker Hill Cheese Company, Inc.	Food and Cosmetics	01/31/2023	Other preventive controls - Implementation records
Robin Industries Healthcare Division	Devices	09/26/2023	Not approved or obsolete document retrieval
Robin Industries Healthcare Division	Devices	09/26/2023	Equipment control activity documentation
Robin Industries Healthcare Division	Devices	09/26/2023	Lack of or inadequate procedures