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 second 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:

• Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
• Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.

The company cited was involved in the Devices and Drugs sectors.

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
Meridian Medical Technologies, Inc.	Devices	06/05/2024	Control procedures to monitor and validate performance
Meridian Medical Technologies, Inc.	Devices	06/05/2024	Procedures for sterile drug products
Meridian Medical Technologies, Inc.	Devices	06/05/2024	Scientifically sound laboratory controls
Meridian Medical Technologies, Inc.	Devices	06/05/2024	Acceptance criteria for sampling & testing
Meridian Medical Technologies, Inc.	Devices	06/05/2024	Investigations of discrepancies, failures
Meridian Medical Technologies, Inc.	Devices	06/05/2024	Design output - Lack of or inadequate procedures
Meridian Medical Technologies, Inc.	Devices	06/05/2024	Design validation - Risk analysis
Meridian Medical Technologies, Inc.	Devices	06/05/2024	Purchasing controls, Lack of or inadequate procedures
Meridian Medical Technologies, Inc.	Devices	06/05/2024	Lack of or inadequate procedures
Meridian Medical Technologies, Inc.	Drugs	06/05/2024	Control procedures to monitor and validate performance
Meridian Medical Technologies, Inc.	Drugs	06/05/2024	Procedures for sterile drug products
Meridian Medical Technologies, Inc.	Drugs	06/05/2024	Scientifically sound laboratory controls
Meridian Medical Technologies, Inc.	Drugs	06/05/2024	Acceptance criteria for sampling & testing
Meridian Medical Technologies, Inc.	Drugs	06/05/2024	Investigations of discrepancies, failures
Meridian Medical Technologies, Inc.	Drugs	06/05/2024	Design output - Lack of or inadequate procedures
Meridian Medical Technologies, Inc.	Drugs	06/05/2024	Design validation - Risk analysis
Meridian Medical Technologies, Inc.	Drugs	06/05/2024	Purchasing controls, Lack of or inadequate procedures
Meridian Medical Technologies, Inc.	Drugs	06/05/2024	Lack of or inadequate procedures