North Columbus News

There were two companies in a city associated with Delaware 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 a 100% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• The stand-alone software that is regulated as a medical device did not provide its unique device identifier through either an easily readable plain-text statement displayed whenever the software is started or an easily readable plain-text statement displayed through a menu command.
• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
• Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.

Both companies cited should take a voluntary action to correct its managing operations (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.

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
Apneicare, LLC	Devices	04/12/2024	Labeling requirements for stand-alone software
Apneicare, LLC	Devices	04/12/2024	Purchasing controls, Lack of or inadequate procedures
Apneicare, LLC	Devices	04/12/2024	Investigation of device failures
Krispy Kreme Doughnut Corporation	Food and Cosmetics	05/09/2024	Sanitary facilities and controls
Krispy Kreme Doughnut Corporation	Food and Cosmetics	05/09/2024	Manufacturing, processing, packing, holding - Controls