North Dayton News

There were two companies in cities associated with Montgomery County that received FDA citations as a result of two inspections conducted in the county over the second quarter of 2024, 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 quarter.

The citations in the county include:

• Rework and reevaluation activities have not been documented in the device history record.
• Procedures for corrective and preventive action have not been adequately established.
• Complaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.

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
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