FDA 483 - Delaware Institute for Reproductive Medicine, P.A - June 20, 2019

The FDA inspected Delaware Institute for Reproductive Medicine, P.A. in Newark, DE, from June 18-20, 2019, and issued a Form 483. The inspection revealed a significant deficiency in donor screening practices, specifically regarding the assessment of risk factors for Zika Virus in oocyte donors. This indicates a serious lapse in ensuring donor eligibility and preventing the transmission of communicable diseases.