FDA 483 - Laurel Fertility Care, A Professional Medical Corporation - February 07, 2023

An FDA inspection of Laurel Fertility Care, a reproductive tissue establishment in San Francisco, revealed two observations. The firm failed to determine HCT/P donor eligibility based on complete screening and testing, specifically processing oocyte donors before reviewing all relevant communicable disease agent or disease testing records. Additionally, donor eligibility records were found to be neither indelible nor legible, with instances of ink obliteration and overwriting.