FDA 483 - Incinta Fertility Center, LLC - May 02, 2023

Incinta Fertility Center, LLC in Torrance, CA, was cited for deficiencies in its handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to quarantine HCT/Ps from donors not adequately screened for Zika Virus and did not apply appropriate warning labels to HCT/Ps from ineligible donors. Additionally, the company lacked established and maintained procedures for testing, screening, and determining the eligibility of HCT/P donors for infectious diseases like HBV NAT, Zika virus, and WNV.