There was one company in a city associated with Loudoun County that received FDA citations as a result of one inspection conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous year.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not fully followed.
- Failure to submit a biological deviation reports.
- Written standard operating procedures including all steps to be followed in the processing and distribution of blood and blood components for allogeneic transfusion, autologous transfusion and further manufacturing purposes were not always maintained.
The company cited was involved in the Biologics 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.
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 |
|---|---|---|---|
| Inova Health Care Services | Biologics | 09/04/2024 | Procedures not in writing, fully followed |
| Inova Health Care Services | Biologics | 09/04/2024 | Who must report – manufacturer |
| Inova Health Care Services | Biologics | 09/04/2024 | Establish, maintain and follow manufacturing SOPs |
| Inova Health Care Services | Biologics | 09/04/2024 | Concurrent documentation |
| Inova Health Care Services | Biologics | 09/04/2024 | Notify Consignees [Collecting Establishment] |
| Inova Health Care Services | Biologics | 09/04/2024 | Notify Consignees [Collecting Establishment] |
| Inova Health Care Services | Biologics | 09/04/2024 | Notify Consignees [Collecting Establishment] |
| Inova Health Care Services | Biologics | 09/04/2024 | Ineligible Donor |



