St. Louis Reporter

There were 11 companies in the City of St. Louis that received FDA citations as a result of 11 inspections conducted in the city throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 57.1% increase over the number of companies cited in the previous year.

Of the 48 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.

Most of the companies cited were involved in the Devices sector. The second most common type of company cited in the time period worked in the Drugs sector.

All of the companies cited should take voluntary actions to correct their 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
Apolo - Megasun, LLC	Devices	08/29/2024	Label to bear a unique device identifier
Apolo - Megasun, LLC	Devices	08/29/2024	Design control - no procedures
Apolo - Megasun, LLC	Devices	08/29/2024	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Apolo - Megasun, LLC	Devices	08/29/2024	Lack of or inadequate final acceptance procedures
Brian Van Tine	Drugs	01/26/2024	FD-1572, protocol compliance
Center for Reproductive Medicine & Robotic Surgery, LLC	Biologics	03/11/2024	Risk factors, clinical evidence
Center for Reproductive Medicine & Robotic Surgery, LLC	Biologics	03/11/2024	SOP for release; reactive for CMV
Matthew A. Powell, M.D.	Drugs	06/03/2024	Safety Reports - Non-Serious Events
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Devices	06/05/2024	Control procedures to monitor and validate performance
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Devices	06/05/2024	Procedures for sterile drug products
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Devices	06/05/2024	Scientifically sound laboratory controls
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Devices	06/05/2024	Acceptance criteria for sampling & testing
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Devices	06/05/2024	Investigations of discrepancies, failures
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Devices	06/05/2024	Design output - Lack of or inadequate procedures
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Devices	06/05/2024	Design validation - Risk analysis
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Devices	06/05/2024	Purchasing controls, Lack of or inadequate procedures
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Devices	06/05/2024	Lack of or inadequate procedures
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Drugs	06/05/2024	Control procedures to monitor and validate performance
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Drugs	06/05/2024	Procedures for sterile drug products
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Drugs	06/05/2024	Scientifically sound laboratory controls
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Drugs	06/05/2024	Acceptance criteria for sampling & testing
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Drugs	06/05/2024	Investigations of discrepancies, failures
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Drugs	06/05/2024	Design output - Lack of or inadequate procedures
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Drugs	06/05/2024	Design validation - Risk analysis
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Drugs	06/05/2024	Purchasing controls, Lack of or inadequate procedures
Meridian Medical Technologies a Subsidiary of Kindeva Drug Delivery, L. P., LLC	Drugs	06/05/2024	Lack of or inadequate procedures
Mid-America Transplant Services	Biologics	08/23/2024	Process validation procedures
Ohlendorf Company	Devices	06/26/2024	Label to bear a unique device identifier
Ohlendorf Company	Devices	06/26/2024	Lack of or inadequate organizational structure
Ohlendorf Company	Devices	06/26/2024	Devices subject to device identification GUDID data submission requirements.
Radialogica, LLC	Devices	03/06/2024	Design review - Lack of or inadequate procedures
Radialogica, LLC	Devices	03/06/2024	Lack of or inadequate procedures
Radialogica, LLC	Devices	03/06/2024	Complaints
Sentiar, Inc.	Devices	03/21/2024	Management review - Lack of or inadequate procedures
Sentiar, Inc.	Devices	03/21/2024	Quality audits - Lack of or inadequate procedures
Sentiar, Inc.	Devices	03/21/2024	Evaluation and Selection, Suppliers, Contractors, etc.
Sentiar, Inc.	Devices	03/21/2024	Lack of or inadequate DHR procedures
Sentiar, Inc.	Devices	03/21/2024	Complaints
Sentiar, Inc.	Devices	03/21/2024	GUDID Information required for unique device identification.
Wan-Gee Foods, Inc.	Food and Cosmetics	05/10/2024	Personnel
Wan-Gee Foods, Inc.	Food and Cosmetics	05/10/2024	Manufacturing, processing, packing, holding - Controls
Wan-Gee Foods, Inc.	Food and Cosmetics	05/10/2024	Process preventive controls - Implement
Wan-Gee Foods, Inc.	Food and Cosmetics	05/10/2024	Process preventive controls - Appropriate (Adequate)