Richmond Leader

There was one company in the City of Richmond that received FDA citations as a result of one inspection conducted in the city throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 75% decrease from the number of companies cited in the previous year.

The citations in the city include:

• Records fail to include documentation of results and interpretation of all required infectious disease tests.
• After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the summary of the records used to make the donor-eligibility determination.
• The summary of records for HCT/Ps from donors determined to be ineligible based on screening and released for limited use did not contain a statement noting the reasons(s) for the ineligibility.

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
VCU Health System Reproductive Medicine and IVF	Biologics	05/12/2023	Results and interpretation of infectious disease tests
VCU Health System Reproductive Medicine and IVF	Biologics	05/12/2023	Summary--records used to make determination
VCU Health System Reproductive Medicine and IVF	Biologics	05/12/2023	Reasons for ineligibility on summary