There were two companies in cities associated with Shelby County that received FDA citations as a result of two inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is an 80% decrease from the number of companies cited in the previous year.
The citations in the county include:
- A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
- Procedures for finished device acceptance have not been adequately established.
- Procedures for corrective and preventive action have not been adequately established.
Of the companies cited, two should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (50%).
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 |
|---|---|---|---|
| AMDT HOLDINGS, Inc. | Devices | 02/23/2024 | Report of risk to health |
| Edge Biologicals, Inc. | Devices | 11/22/2024 | Lack of or inadequate process validation |
| Edge Biologicals, Inc. | Devices | 11/22/2024 | Lack of or inadequate final acceptance procedures |
| Edge Biologicals, Inc. | Devices | 11/22/2024 | Lack of or inadequate procedures |
| Edge Biologicals, Inc. | Devices | 11/22/2024 | Lack of or inadequate complaint procedures |
