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 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged 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 has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
• Procedures for training and identifying training needs have not been established.
• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.

The company cited was involved in the Devices sector.

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.

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
Allied Medical, LLC	Devices	11/08/2023	Individual Report of Malfunction
Allied Medical, LLC	Devices	11/08/2023	Training - Lack of or inadequate procedures
Allied Medical, LLC	Devices	11/08/2023	Purchasing controls, Lack of or inadequate procedures
Allied Medical, LLC	Devices	11/08/2023	Contamination control, Lack of or inadequate procedures
Allied Medical, LLC	Devices	11/08/2023	Lack of or inadequate procedures
Allied Medical, LLC	Devices	11/08/2023	Lack of or inadequate complaint procedures
Allied Medical, LLC	Devices	11/08/2023	Service reports