FDA WARNING_LETTER - Sperm Bank, Inc. dba Fertility Center of California - June 12, 2024

On February 14, 2025, the FDA issued a Warning Letter to Sperm Bank, Inc. dba Fertility Center of California following an inspection from June 7-12, 2024. The inspection revealed significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to test for relevant communicable disease agents:** Repeat anonymous semen donors were not tested for West Nile Virus (WNV) using an FDA-licensed NAT donor screening test at the time of the first donation within the June 1st to October 31st testing period. 2. **Failure to perform complete donor screening:** Complete donor screening procedures, including review of relevant medical records (medical history interview and physical assessment), were not performed within the required six-month period for repeat donors before semen was released from quarantine. 3. **Failure to collect donor specimens for testing within the required timeframe:** Specimens for communicable disease testing were not collected at the time of recovery or within seven days before or after recovery for multiple donors. 4. **Failure to establish and maintain adequate procedures:** Procedures did not include WNV NAT as a required test for relevant communicable disease agents during the specified testing period.

The firm's June 25, 2024, response was deemed inadequate.