FDA 483 - Sher Fertility Solutions New York - June 10, 2019

Libera Medical, PLLC, a reproductive tissue establishment in New York, NY, was inspected and cited for significant deficiencies in donor screening and record-keeping practices. Observations included inadequate screening for communicable diseases like West Nile and Zika viruses, and failures to maintain donor anonymity in identification codes and records. The firm also lacked proper procedures for donor eligibility testing and identification code assignment.