St. Louis Reporter

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