North Dayton News

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

This is a 50% decrease from the number of companies cited in the previous year.

The citations in the county include:

• You did not maintain your plant in a clean and sanitary condition and in adequate repair.
• You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against allergen cross-contact and contamination of food.
• Evaluations of out-of-calibration equipment and remedial actions taken were not documented.

Most of the companies cited were involved in the Devices sector.

All of the 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.

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
AVI Foodsystems, Inc.	Food and Cosmetics	04/17/2024	Modified requirement: Temperature control - Implement
AeroBiotix, LLC	Devices	04/11/2024	Product rework documentation, DHR {see also 820.184}
AeroBiotix, LLC	Devices	04/11/2024	Lack of or inadequate procedures
AeroBiotix, LLC	Devices	04/11/2024	Investigation of device failures
Life Sciences Vandalia	Devices	09/06/2024	Remedial action - documentation
Life Sciences Vandalia	Devices	09/06/2024	Documentation
Life Sciences Vandalia	Devices	09/06/2024	Complaints
Lincotek Medical, LLC.	Devices	09/26/2024	Lack of or inadequate process validation
Mar-Chele, Inc.	Food and Cosmetics	03/14/2024	Sanitary operations - Plant maintenance
Mar-Chele, Inc.	Food and Cosmetics	03/14/2024	Sanitation of food-contact surfaces - Frequency