FDA 483 - Fertility Center of Dallas - August 25, 2021

The FDA issued a Form 483 to Fertility Center of Dallas following an inspection of their reproductive HCT/P establishment. The inspection revealed a failure to establish and maintain adequate procedures for testing and screening HCT/P donors. Specifically, the firm lacked instructions for reviewing Zika Virus screening questions and failed to list the West Nile Virus NAT in their procedures.