There was one company in a city associated with Shelby County that received an FDA citation as a result of one inspection conducted in the county over the first quarter of 2026, according to the U.S. Food and Drug Administration (FDA).
No companies were cited in the previous quarter.
The only citation issued in the county was delivered as ‘A risk-based approach to the control of the appropriate processes needed for the quality management system has not been adequately applied’.
The company cited should take a voluntary action to correct its 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.
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Onyx Medical, LLC | Devices | 02/13/2026 | Risk-based approach not applied to QMS processes |
