West Nova News

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 in September, 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 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.

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
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