FDA 483 - Vaughn, Silverberg and Associates, LLP - August 23, 2021

An FDA inspection of Vaughn, Silverberg and Associates, LLP, a fertility clinic in Austin, TX, identified one observation. The firm failed to include the reasons for donor ineligibility in the summary of records for HCT/Ps from donors released for limited use. This was specifically noted for directed donors who had traveled to an active Zika area.