FDA 483 - Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center - December 22, 2022

The FDA inspected Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center, a reproductive fertility center in Irvine, CA. The inspection revealed significant deficiencies in donor screening and eligibility determination for oocyte donors, specifically regarding Zika and West Nile viruses. Additionally, the firm failed to maintain donor anonymity by including personal identifying information on accompanying HCT/P records.