There was one company in the City of St. Louis that received FDA citations as a result of one inspection conducted in the city over the fourth quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 50% decrease from the number of companies cited in the previous quarter.
The citations in the city include:
- An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
- Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Allied Medical, LLC | Devices | 10/30/2024 | Report of Death or Serious Injury |
| Allied Medical, LLC | Devices | 10/30/2024 | Purchasing controls, Lack of or inadequate procedures |
| Allied Medical, LLC | Devices | 10/30/2024 | Contamination control, Lack of or inadequate procedures |
| Allied Medical, LLC | Devices | 10/30/2024 | Lack of or inadequate process validation |
| Allied Medical, LLC | Devices | 10/30/2024 | Lack of or inadequate procedures |
