Wichita Standard

There was one company in a city associated with Sedgwick County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2024, 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 quarter.

The citations in the county include:

• Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
• Failure to notify transfusion recipients who received previous collections of blood and blood components at increased risk of transmitting HIV infection, the physician of record for transfusion recipients who received previous collections of blood and blood components at increased risk of transmitting HIV infection and the legal representative or relative of transfusion recipients who received previous collections of blood and blood components at increased risk of transmitting HIV infection of the need for recipient HIV testing and counseling.
• Failure to notify transfusion recipients who received previous collections of blood and blood components at increased risk of transmitting HCV infection and the physician of record for transfusion recipients who received previous collections of blood and blood components at increased risk of transmitting HCV infection of the need for recipient HCV testing and counseling.

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
Wesley Medical Center	Biologics	12/10/2024	Written calibration / inspection records not kept
Wesley Medical Center	Biologics	12/10/2024	Notify Transfusion Recips or MD of Record [Consignee]
Wesley Medical Center	Biologics	12/10/2024	Notify Transfusion Recipients or MD of Record [Consignee]