FDA 483 - Main Line Fertility Center - June 30, 2022

An FDA inspection of Main Line Fertility Center in Bryn Mawr, PA, identified two significant observations related to the handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to quarantine HCT/Ps until donor eligibility was complete and did not properly label HCT/Ps for which donor eligibility determination was not required. These issues indicate deficiencies in the facility's procedures for ensuring the safety and compliance of reproductive tissues.