FDA 483 - Community Fertility Specialty Care - January 11, 2024

An FDA inspection of Community Fertility Specialty Care in Indianapolis, IN, revealed significant deficiencies in donor eligibility determination and communicable disease testing for oocyte donors. The firm failed to test donors for relevant communicable diseases like West Nile Virus and Hepatitis B, and did not maintain proper documentation for donor eligibility. Additionally, the facility's procedures were inadequate to ensure compliance with required donor screening tests.