There were nine companies in cities associated with Franklin 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 30.8% decrease from 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 |
