There were three companies in cities associated with Summit County that received FDA citations as a result of three inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 25% decrease from the number of companies cited in the previous year.
The citations in the county include:
- You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against allergen cross-contact and contamination of food.
- Written standard operating procedures including all steps to be followed in the processing, compatibility testing and distribution of blood and blood components for allogeneic transfusion were not always followed.
- Procedures have not been adequately established to control product that does not conform to specified requirements.
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.
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 |
|---|---|---|---|
| A & A Vending Company, Inc. | Food and Cosmetics | 08/29/2023 | Sanitation of food-contact surfaces – Frequency |
| Ekso Bionics, Inc. | Devices | 12/21/2023 | Nonconforming product, Lack of or inadequate procedures |
| Summa Health System | Biologics | 03/21/2023 | Establish, maintain and follow manufacturing SOPs |
