North Columbus News

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

This is a 28.6% increase over the number of companies cited in the previous year.

Of the 20 citations issued, the most common citation was 'Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established'.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, eight should take voluntary actions to correct their managing operations (88.9%).

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
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
Auddinos Italian Bakery, Inc.	Food and Cosmetics	08/22/2024	Personnel
Auddinos Italian Bakery, Inc.	Food and Cosmetics	08/22/2024	Storage and Distribution
Bertec, Corp.	Devices	02/12/2024	Purchasing controls, Lack of or inadequate procedures
Big Lots, Inc.	Food and Cosmetics	02/06/2024	Verification activity before import, periodically
Entrotech Life Sciences, Inc.	Devices	07/01/2024	Quality audits - auditor independence
Entrotech Life Sciences, Inc.	Devices	07/01/2024	Lack of or inadequate procedures
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
Ocean Providence Columbus, LLC	Food and Cosmetics	06/11/2024	Food safety hazards
Sammy s Bagels, LLC	Food and Cosmetics	11/18/2024	Qualifications of individuals
Sammy s Bagels, LLC	Food and Cosmetics	11/18/2024	Plant construction and design
Sammy s Bagels, LLC	Food and Cosmetics	11/18/2024	Sanitary operations - Plant maintenance
Sammy s Bagels, LLC	Food and Cosmetics	11/18/2024	Cleaning and sanitizing substances - Safe and adequate
Sammy s Bagels, LLC	Food and Cosmetics	11/18/2024	Manufacturing, processing, packing, holding - Controls
Unified Spine, LLC	Devices	03/01/2024	Design changes - Lack of or Inadequate Procedures
Unified Spine, LLC	Devices	03/01/2024	Procedures not adequately established or maintained
Unified Spine, LLC	Devices	03/01/2024	Purchasing controls, Lack of or inadequate procedures