FDA 483 - Fertility Center of San Antonio - May 24, 2021

The FDA inspected Fertility Center of San Antonio and issued a Form 483 with two observations related to donor screening and record-keeping for reproductive tissues. The firm failed to adequately screen donors for communicable disease risks, specifically Zika Virus, by not including necessary questions on donor questionnaires. Additionally, their eligibility summary forms for HCT/Ps lacked a required statement confirming that communicable disease testing was performed by a CLIA-certified laboratory.