There were two companies in the City of St. Louis that received FDA citations as a result of two inspections conducted in the city in March, according to reports from the U.S. Food and Drug Administration (FDA).
This is an increase over the number of companies cited in the previous month.
The citations in the city include:
- Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
- A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not established.
- Procedures for design review have not been adequately established.
Both 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.
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 |
|---|---|---|---|
| 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 |
| 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 |
