Findlay Times

There were two companies in cities associated with Seneca County that received FDA citations as a result of two inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous year.

The citations in the county include:

• The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
• The design history file was not established and does not demonstrate that the design was developed following the approved design plan.
• Process validation activities and results have not been adequately documented.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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.

According to its website, 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.

Company Name	Area of Business	Inspection Date	Issue Cited
American Contract Systems, Inc.	Devices	08/14/2024	Lack of or inadequate organizational structure
American Contract Systems, Inc.	Devices	08/14/2024	Design history file
American Contract Systems, Inc.	Devices	08/14/2024	Documentation
American Contract Systems, Inc.	Devices	08/14/2024	Lack of or inadequate receiving acceptance procedures
Archer Daniels Midland Company	Veterinary	01/08/2024	Holding and Distribution