There were two companies in cities associated with Summit County that received FDA citations as a result of two inspections conducted in the county over the first 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:
- You did not have a written food safety plan.
- Written MDR procedures have not been developed.
- The type and extent of control to be exercised over the product, services and suppliers was not clearly defined.
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 |
|---|---|---|---|
| A & A Vending Company, Inc. | Food and Cosmetics | 02/22/2024 | Food safety plan |
| Omega Laboratories, Inc. | Devices | 02/08/2024 | Lack of Written MDR Procedures |
| Omega Laboratories, Inc. | Devices | 02/08/2024 | Supplier oversight |
| Omega Laboratories, Inc. | Devices | 02/08/2024 | Acceptable supplier records, inadequate records |
| Omega Laboratories, Inc. | Devices | 02/08/2024 | Lack of or inadequate procedures |
| Omega Laboratories, Inc. | Devices | 02/08/2024 | Lack of or inadequate complaint procedures |
