Central Virginia Times

There was one company in the City of Charlottesville that received FDA citations as a result of one inspection conducted in the city 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 city include:

• Equipment used in the processing of blood and blood components is not observed, standardized and calibrated on a regularly scheduled basis as prescribed in the SOP Manual.
• Written standard operating procedures including all steps to be followed in the compatibility testing and distribution of blood and blood components for allogeneic transfusion were not always maintained.
• Records including signature by the physician requesting the procedure are not maintained of all emergency transfusions including complete documentation justifying the emergency action.

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
University Of Virginia Health System	Biologics	09/12/2024	Equipment observed, standardized, calibrated
University Of Virginia Health System	Biologics	09/12/2024	Establish, maintain and follow manufacturing SOPs
University Of Virginia Health System	Biologics	09/12/2024	Procedures to maintain records of emergency transfusions