FDA 483 - Main Line Fertility Center - June 30, 2022
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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.
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ID · e61c7beb-3bb1-4117-9062-bf1a7a332dcf