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.
Companies Located Within City of St. Louis and the Citations They Received in 2024
| 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) |
