South Tidewater News

There were three companies in the City of Virginia Beach that received FDA citations as a result of three inspections conducted in the city throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 200% increase over the number of companies cited in the previous year.

The citations in the city include:

• You did not establish and maintain procedures for screening of HCT/P donors.
• HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
• 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.

Most of the companies cited were involved in the Biologics sector.

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).

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
American Red Cross	Biologics	09/07/2023	Storage temps./agitation
Contour Healer, LLC	Devices	09/15/2023	Management review - defined interval, sufficient frequency
Contour Healer, LLC	Devices	09/15/2023	Evaluation of suppliers, contractors, etc., requirements
Contour Healer, LLC	Devices	09/15/2023	Lack of or inadequate procedures - Acceptance activities
The New Hope Center For Reproductive Medicine	Biologics	01/20/2023	Testing, screening, donor eligibility procedures
The New Hope Center For Reproductive Medicine	Biologics	01/20/2023	Determination based on screening and testing
The New Hope Center For Reproductive Medicine	Biologics	01/20/2023	Summary--records used to make determination
The New Hope Center For Reproductive Medicine	Biologics	01/20/2023	Risk factors, clinical evidence
The New Hope Center For Reproductive Medicine	Biologics	01/20/2023	Abbreviated procedure
The New Hope Center For Reproductive Medicine	Biologics	01/20/2023	Specimen collections not timely